Metabolic syndrome definitions—similar but different enough.
Similar ambiguity exists concerning the definition of adequate circulating VitD level, as well as of its deficiency and insufficiency. Earlier definition of VitD insufficiency by its blood level of <20 ng/mL (50 nmol/L), given by the World Health Organization (WHO) [14], has been recently accepted by most researchers as a definition of the deficiency of this vitamin [15, 16]. Its insufficiency is defined as a VitD concentration between 20 and 30 ng/mL (50 and 75 nmol/L), while its concentrations >30 ng/mL (75 nmol/L) are regarded as sufficient [17, 18].
\nThe WHO definition10 | \nNCEP ATP III definition11 | \nIDF definition12 | \n||
---|---|---|---|---|
Insulin resistance plus ≥ 2 of: | \n≥ 3 of: | \n\n | ||
\n | Central obesity | \nplus 2 of: | \n||
\n | Atherogenic dyslipidaemia | \n\n | ||
\n | Hypertension | \n\n | ||
Microalbuminuria | \nImpaired fasting glucose/Glucose intolerance/Diabetes | \n
Metabolic syndrome definitions—similar but different enough.
Study included a total of 137 APS patients, attending outpatient clinic of the University Medical Center Bezanijska kosa, all Caucasians, who were previously enrolled in Serbian National APS Registry. These patients represented only the part of those so far included in this Registry, which is still growing and is still unable to appraise the prevalence of APS among general population in Serbia. Among studied patients, 68 were PAPS patients (59 females, nine males, mean age 43.51+10.58 years) and 69 sAPS patients (61 females, eight males; mean age 47.83+15.67 years). All studied APS patients have met 2006 updated Sydney criteria [5] which requested the presence of at least one clinical criteria (i.e. vascular thrombosis or multiple and recurrent foetal losses) and at least one of antiphospholipid antibodies (aPL), i.e. lupus anticoagulant (LA), anticardiolipin (aCL) and/or anti‐β2‐glycoprotein 1 (β2GP1) antibodies. Most of our sAPS patients had APS associated with systemic lupus erythematosus (SLE) (n=60; 87%), while the rest had Sjögren\'s syndrome (n=8; 11.5%) and ankylosing spondylitis (n=1; 1.5%). Mean duration of these rheumatic diseases in sAPS patients was 5.69+2.87 years, ranging from 1 to 13 years.
\nCharacteristics of two subgroups of APS patients were compared with 50 MetS patients (35 females, 15 males; mean age 47.68+11.66 years). The presence of metabolic syndrome among studied patients was determined according to the International Diabetes Federation (IDF) clinical definition [12]. An obligatory criterion for MetS requested by this definition is abdominal obesity defined by elevated waist circumference (WC) with gender‐ and ethnic‐specific cut‐offs, meaning 94 cm for males, and 80 cm for females belonging to European population. Besides abdominal obesity, two or more of the four additional criteria (a) hypertriglyceridemia >150 mg/L, confirmed or already treated; (b) high density lipoprotein (HDL) cholesterol <40 mg/dL in males or <50 mg/dL in females; (c) blood pressure >130/85 mmHg, newly diagnosed or already treated; (d) impaired fasting glycaemia, >100 mg/dL or previously diagnosed diabetes) are necessary for the diagnosis.
\nFor every participant, clinical data concerning thrombotic events, their appearance, management and follow‐up were obtained from medical charts review. As thrombotic events, the following were recorded: superficial and deep venous thrombosis, pulmonary embolism, peripheral arterial occlusion, cerebral vascular accident and myocardial infarction.
\nAfter an overnight fast, height (m), weight (kg) and waist circumference (cm) were measured in every participant with underwear and without shoes. Waist circumference (WC) was measured at the level of the umbilicus while the participant was standing and breathing normally. Body mass index (BMI) was calculated according to the widely accepted formula dividing body weight by the square of individual\'s height. Morning samples of venous blood (3–5 mL) were withdrawn from every participant for the analysis of serum glucose and lipids. Serum vitamin D levels were determined in every participant .
\nThe study was approved by the Institutional Ethics Committee. All examinations were conducted according to the most recent amendment of Declaration of Helsinki (Edinburgh, 2000), only after obtaining an informed consent for participation in the study from every subject.
\nStatistical analysis was performed using the STATISTICA 10 software program. Descriptive statistics was used. Prevalence of MetS as well as of its individual components, within studied groups of patients was expressed as percentage. Testing significance of their differences, the Student\'s t‐test and Fisher\'s exact test were used, considering p value <0.05 statistically significant.
\nMetabolic syndrome was observed in high percentage of patients with APS. Its prevalence did not differ significantly between PAPS (36.76%) and sAPS (42.03%) patients (p=0.53).
\nAnthropometric and metabolic syndrome characteristics among studied groups are given in Table 3. Borderline statistical significance of the difference in WC value was observed when two subgroups of APS patients were compared with MetS patients (F=2.77, p=0.065), while BMI has differed highly significantly between these groups (F=9.765, p=0.0001). In spite of slightly lower BMI and slightly higher WC in PAPS patients, neither BMI (p=0.434) nor WC (p=0.275) did differ significantly between two subgroups of APS patients.
\nAtherogenic dyslipidaemia, represented by hypertriglyceridemia and low HDL cholesterol, was the most prevalent characteristic of metabolic syndrome among PAPS patients. In spite of this, prevalence of low HDL cholesterol among PAPS patients were significantly lower than in MetS patients (48.3% vs. 70%, p=0.02). Prevalence of hypertriglyceridemia (45.59% vs. 42.03%, p=0.67) and low HDL cholesterol (48.53% vs. 53.62%, p=0.55) did not differ significantly between PAPS and sAPS patients. Hypertension was significantly less prevalent among these patients compared with MetS (23.53% vs. 58%, p=0.0002) and even with sAPS (23.53% vs. 52.17%, p=0.0007) patients. The least prevalent characteristic of metabolic syndrome among patients with APS was hyperglycaemic disorder. Compared with MetS patients in whom impaired fasting glycaemia, glucose intolerance or diabetes were present in as much as 36%, these disorders were observed in only 5.88% of PAPS patients (p=0.0001) and 4.35% of sAPS patients (p<0.0001).
\n\n | MetS | \nPAPS | \nsAPS | \n
---|---|---|---|
BMI (kg/m2) | \n32.09+6.14 | \n27.81+5.98 | \n28.54+4.22 | \n
WC (cm) | \n93.67+14.36 | \n90.73+9.18 | \n88.53+11.91 | \n
TG > 150 mg/dL (%) | \n58 | \n45.59 | \n42.03 | \n
HDL < 40/50 mg/dL (%) | \n70 | \n48.53** | \n53.62 | \n
Hypertension (%) | \n58 | \n23.53**** | \n52.17§§ | \n
IFG, IGT, DM (%) | \n36## | \n5.88**** | \n4.35 | \n
Anthropometric and metabolic syndrome characteristics among studied groups.
*p < 0.05, PAPS vs. MetS.
**p < 0.01, PAPS vs. MetS.
#p < 0.01, sAPS vs. MetS.
§p < 0.01, PAPS vs. sAPS.
Compared with patients with metabolic syndrome, prevalence of thrombotic events was significantly higher among patients with PAPS (52.94% vs. 22%, p=0.0009) and sAPS (56.52% vs. 22%, p=0.0003). Thrombotic events were reported with similar prevalence in PAPS and sAPS patients (p=0.674).
\nWhen compared with APS patients without characteristics of MetS, thrombotic events were significantly more frequent among MetS positive patients with sAPS (75.86% vs. 42.5%, p=0.0075).
\nAlthough higher among MetS positive, compared with MetS negative patients with PAPS, difference of prevalence of thrombotic events among these two subgroups of PAPS patients did not reach statistical significance (68% vs. 44.19%, p=0.0622).
\nLow VitD status (insufficiency or deficiency) was highly prevalent among PAPS (insufficiency in 27.94% and deficiency in 36.76%) and sAPS patients (insufficiency in 30.43% and deficiency in 40.58%), as well as among patients with pure MetS (insufficiency in 20% and deficiency in 32%).
\nIn comparison with patients with pure MetS (28.58+14.32 ng/mL), VitD concentrations were lower in PAPS (25.76+12.18 ng/mL) and sAPS patients (23.81+11.22 ng/mL), but with statistically significant difference only between these concentrations in sAPS patients and patients only with MetS (p=0.04).
\nSignificantly lower VitD level was observed in those with coexisting MetS (MetS +), compared with those without it (MetS -) both in PAPS (MetS +: 22.0+8.52 vs. MetS -: 27.0+13.49 ng/mL, p=0.05 ) and sAPS patients (MetS +: 18.83+9.16 vs. MetS -: 27.42+11.28 ng/mL, p=0.0012).
\nAlso, significantly lower VitD level was observed in APS patients with thrombotic events (TE+), compared with those without these events (TE -), both in PAPS (TE +: 20.61+12.18 vs. TE -: 31.56+12.72 ng/mL, p=0.0001 ) and sAPS patients (TE +: 20.67+10.43 vs. TE -: 27.9+11.04 ng/mL, p=0.007).
\nIn 11 (22%) of patients with MetS, but without APS, some thrombotic event was confirmed. In those patients, VitD levels were also significantly lower than in those without these events (TE +: 18.45+10.66 vs. TE -: 31.43+13.63 ng/mL, p=0.003).
\nHowever, both in PAPS and sAPS patients, with coexisting MetS, previous thrombotic events did not influence serum VitD levels (PAPS: p=0.12; SAPS: p=0.93).
\nEstimation of prevalence of MetS in general population seems to depend to a substantial degree on the used definition, at least in certain countries or in certain ethnic groups [19–22]. Its prevalence varies between <10% in China and as much as 60% among women of Samoa [23]. Different prevalences of MetS, ranging between 18 and 48%, were also recorded among populations of different European countries and regions [20–22, 24–26]. It is interesting to emphasize that even in populations in which comparable prevalence of MetS was found using each of three already mentioned definitions, level of agreement between them was not good. As could be expected, worse agreement was found between WHO‐NCEP ATP III and WHO‐IDF than between NCEP ATP III‐IDF definitions because of the central obesity as common denominator of the last two definitions [20, 21, 23]. This observation raised the possibility that in fact different individuals were identified as having MetS by different definitions of this syndrome [23].
\nIn a search for factors that contribute to the manifestations of APS, MetS came into a focus surprisingly late. Data on coexistence of these two syndromes are still relatively scarce, particularly considering that of MetS and primary APS (PAPS).
\nRecently, prevalence of MetS among PAPS patients has been assessed by Medina et al. [3] and Rodrigues et al. [27]. Both surveys were performed in Hispanics among whom MetS has the highest prevalence [28]. Defined by the IDF criteria, the prevalence of MetS among 71 Brazilian PAPS patients was 33.8% [27]. Comparable prevalences of MetS were recorded among 58 Mexican PAPS patients, using NCEP ATP III (34.5%) or IDF definitions (37.9%), while it was only 17.2% when WHO definition was applied [3]. It has been hypothesized that these cases, identified by WHO definition, were insulin resistant and with more severe forms of MetS [3, 29]. However, in investigation conducted by Medina et al., prevalence of MetS among PAPS patients was higher than in corresponding general population (17.2% vs. 13.6%) when WHO definition was used [3]. Same as in general population without APS [20, 21, 23], among PAPS patients agreement between WHO and NCEP ATP III definitions of MetS was low (κ value 0.394), moderate between WHO and IDF definitions (κ value 0.427), while only between NCEP ATP III and IDF definitions agreement was good (κ value 0.851) [3].
\nRegarding individual components of MetS, atherogenic dyslipidaemia was most prevalent among Mexican PAPS patients, being present in approximately half of them [3]. Significantly higher mean triglyceride levels and significantly lower mean HDL levels were previously reported among PAPS patients in comparison with controls [30–33]. Some specific autoantibodies could influence lipoprotein levels and effects in these patients. These antibodies may interfere with paraoxonase (PON) activity of HDL and, indirectly, beta‐2‐glycoprotein I (beta‐2‐GPI) [32, 33], thus promoting LDL oxidation. Relationships between lipid profile, certain anti‐lipoprotein antibodies, inflammatory markers and clinical manifestations of PAPS were meticulously investigated [31–33], but on relatively small number of patients and with inconsistent results. Delgado Aves et al. have not demonstrated any correlation between the observed decrease in PON activity and either aPL nor antibodies against HDL (anti‐HDL) in PAPS patients [33]. However, pro‐inflammatory and prothrombotic roles were proposed for anti‐HDL, being present in higher titre among asymptomatic persistently aPL positive subjects, as well as in PAPS patients with thrombotic events, when compared with patients with inherited thrombophilia and healthy controls [32]. It has been also hypothesized that hypertriglyceridemia could be the result of decreased degradation as a consequence of an inhibition of lipoprotein lipase (LPL) by aPL [3]. Currently, there are only scarce data on prevalence of antibodies against LPL (anti‐LPL) in PAPS patients, speaking against their existence and influence [31].
\nDifferent authors have observed similar prevalences of hypertension among PAPS patients (22.4 and 26.3%) [3, 31], not differing significantly from that in controls (20%). Nevertheless, among PAPS patients, hypertension was significantly more frequent in those with arterial thrombosis, with which it was independently associated [31]. It is interesting that in spite of highly prevalent insulin resistance (32.8%), hyperglycaemic disorders were present in only 5% of PAPS patients [3].
\nThe literature data on coexistence of MetS and numerous rheumatic diseases (i.e. systemic lupus erythematosus, rheumatoid arthritis, Sjögren\'s syndrome, ankylosing spondylitis, osteoarthritis, gout) are fairly extensive [1, 34–42]. The prevalence of MetS among patients with these disorders ranges between 14 and 62.8% [1, 3]. Qualifier “antiphospholipid syndrome associated with certain autoimmune rheumatic disease” (sAPS), which replace currently obsolete term “secondary APS”, refers mainly to the systemic lupus erythematosus (SLE) despite the still unscrambled puzzle of their relations [5].
\nIt has been speculated that high prevalence of MetS among these patients might be the consequence of certain pharmacologic interventions, particularly of chronic corticosteroid therapy [43]. However, the presence of MetS in as much as 16% of 1494 young (35.2+13.4 years) SLE patients with rather short disease duration (24.1+18.0 weeks) seems to be enough to reject this relationship as causal [2]. Nevertheless, it should be kept in mind that duration and magnitude of corticosteroid exposure could aggravate well‐known cardiovascular risk factors clustering as characteristics of MetS.
\nOn the other hand, other pharmacological interventions, primarily methotrexate (MTX) use in patients with rheumatoid arthritis, have been depicted as independent factors for reduced prevalence of MetS in these patients, especially those older than 60 years [44, 45]. This beneficial effect of MTX was attributed to its anti‐inflammatory, as well as to some still unclear drug‐specific effects, i.e. affecting adenosine levels and, concomitantly, glucose and lipid metabolism, or decreasing homocysteine levels as an indirect effect of simultaneous use of folic acid [44]. However, other authors reported somewhat conflicting results not being able to confirm decreasing prevalence of MetS in subjects treated with MTX, among total of 353 patients with rheumatoid arthritis [46].
\nProthrombotic state is one of the well‐known characteristics of both antiphospholipid and metabolic syndrome. It has rather complex pathogenesis in which VitD status has an important role affecting primarily immune‐mediated thrombosis. Indirect proofs for this relationship are as follows: (a) existence of nuclear VitD receptors in vascular smooth muscle cells, endothelial cells, cardiomyocytes, platelets, as well as in most types of the immune cells [47–51], and (b) expression of cytochrome P450 enzyme, CYP27B1 activity by the same cell types, enabling local synthesis of biologically active form of VitD, 1,25(OH)2D [52].
\nThere is substantial experimental data indicating that VitD plays significant role in maintenance of physiological balance between thrombosis and haemostasis [47]. It has been demonstrated that VitD exerts following actions:\n
in monocytes, expression of tissue factor (TF) is downregulated, while the expression of thrombomodulin (TM) is upregulated [53];
in vascular smooth muscle cells, the expression of TM is upregulated, but there is also downregulation of plasminogen activator inhibitor‐1 (PAI‐1) and thrombospondin‐1 (THSP‐1) [54];
in endothelial cells, platelet activation is attenuated as well as the expression of vascular cell adhesion molecule‐1 (VCAM‐1) [55].
Net result of numerous effects of this vitamin on different haemostatic factors is its antithrombotic role. Prothrombotic state that exists in VitD receptor knockout animal models proves the importance of these extra‐skeletal effects of VitD as well as the observation that all of them are VitD receptor‐mediated [47, 56].
\nHowever, there are still relatively few indirect and even less direct clinical evidences for the association between VitD status and thrombotic events in humans. First of them came from the epidemiological studies in which have been observed that cardiovascular morbidity and mortality depended on season of the year and latitude [47, 57, 58]. Seasonal variations were also demonstrated for tissue plasminogen activator (tPA) antigen, fibrinogen, D‐dimer and von Willebrand factor (vWF) concentrations in 6538 British subjects without significant cardiovascular disorders, aged 45 years [59]. In this population, negative correlation between VitD level and tPA, fibrinogen and D‐dimer concentrations was observed indicating that at least some of the seasonal variations of these thrombotic markers could be attributed to the VitD status. More direct proof for the association between VitD status and thrombosis came from the research conducted in huge population of 18 791 subjects from general population of Copenhagen [60]. Authors have observed that every quartile of a decrease in VitD concentrations was accompanied by an increase in risk of venous thromboembolism (VTE), resulting in a 37% increased VTE risk between subjects with the VitD concentrations, in the lowest quartile and those in highest quartile.
\nRecent publication which retested the seasonality of different cardiovascular events in regard to VitD levels, in the Scottish Heart Health Extended Cohort (SHHEC), brings a dose of confusion in previously proposed relations. Namely, it failed to prove that seasonal appearance of cardiovascular events resembled seasonal variations in serum VitD concentrations nor that these events expressed more pronounced seasonality in those with lower VitD concentrations, compared with those with its higher concentrations [61]. But, during follow‐up, significant correlations were observed between lower baseline concentrations of VitD and subsequent incident cardiovascular morbidity and incident cardiovascular and all‐cause mortality [61].
\nResults of recent trials assessing the effects of VitD supplementation on the risk of thromboembolism were inconclusive [62–64]. In the Multiple Environmental and Genetic Assessment (MEGA) case‐control study which included 2506 patients with venous thrombosis, thrombotic risk was 37% lower in those supplemented with various vitamins including VitD [62]. However, in a large cohort of postmenopausal women (n=36282) from the Women\'s Health Initiative, daily supplementation with calcium and VitD failed to reduce the overall risk of thromboembolism [63]. Even when high doses (300,000 IU) of VitD were given intramuscularly, in a small group of patients with proven deep vein thrombosis and pulmonary embolism, observed reduction in plasma concentrations of P‐selectin and high‐sensitive C‐reactive protein (hs‐CRP) did not reached statistical significance [64]. Additional information could be expected from the ongoing Vitamin D and OmegA‐3 Trial (VITAL) and that is why the results of this investigation are eagerly awaited [65].
\nCurrently, increasing prevalence and co‐existence of obesity, MetS and hypovitaminosis D represent serious public health concern [66, 67]. New data have considerably changed hierarchy of MetS components, with the shift of the focus from obesity and insulin resistance, firstly toward fatty liver and now toward VitD deficiency [68].
\nIt is still questionable if relationship between VitD status and obesity is unidirectional or bidirectional, with the accumulating evidence favouring the influence of VitD on body composition and not vice versa. Namely, few years ago tempting hypothesis on essential role of VitD in evolvement of obesity has been postulated [68]. It started from a situation that is completely opposite to the “thrifty genotype hypothesis” proposed long ago [69] and gave the feasible explanation not only for obesity and MetS epidemic in adults but also for their growing prevalence among children [70]. According to this hypothesis, we are living in “obesogenic” environment, loaded with energy resources and unsuitable for efficient metabolism. It has been proposed that VitD as an ultraviolet (UV)‐B radiation sensor (i.e. decline in its concentrations) could induce shift toward “winter metabolism”, characteristic for MetS [68]. If this is true, then it could be expected that VitD supplementation may be efficient in prevention and treatment of obesity and MetS. Significant decrease in body fat mass after 12 week of VitD repletion (25 μg of cholecalciferol daily), compared to placebo (−2.7+2.0 kg vs. −0.4+2.0 kg, p<0.001), could be the proof for this presumption [71]. It was also speculated that VitD deficiency during pregnancy could lead to the epigenetic changes predisposing, in that manner, new‐born children to obesity and MetS later in life [68, 70]. Experimental support for these assumptions is the expression of VitD receptors on adipocytes and its involvement in adipogenesis which is regulated by the intracellular concentrations of VitD [72], as well as inhibition of lipid accumulation in adipocytes and their atrophy achieved by the knock‐down of VitD receptors [72, 73].
\nNowadays, VitD deficiency is common even in general population (49%), but significantly more prevalent (p=0.006) and quite similar in overweight/obese patients with MetS (72%) and without MetS (69%) [74]. Premise that exaggerated adiposity could lead to VitD insufficiency or deficiency by its seclusion within adipose tissue could not be confirmed. It has been shown that VitD concentrations varied considerably (range 4–2470 ng/g) in the subcutaneous abdominal fat of 17 severely obese patients (BMI=48.7+8.1 kg/m2) undergoing bariatric surgery [75]. In spite of the average weight loss of 54.8 kg after one year and continuous VitD supplementation with more than 2500 IU/day, mean serum VitD concentrations did not change significantly during this period (23.1+12.6 vs. 26.2+5.36, p=0.58) [75].
\nMost of the studies have confirmed that serum VitD concentrations significantly inversely correlated with obesity parameters, BMI (r=-0.159, p=0.007) [74], or waist circumference (p<0.001) [76] as well as with serum triglycerides (r=-0.149, p=0.012) [76]. In the lowest quartiles of VitD concentrations corresponding to its severe deficiency, odds ratio (OR) for hypertriglyceridemia was 2.74 (95% CI: 1.64–4.57) [77]. This association between serum concentrations of VitD and triglycerides could be explained by the activation of lipoprotein lipase by VitD in adipocytes [76]. No significant relation could be demonstrated between VitD status and total‐ (r=-0.044, p=0.461) [74], low density lipoprotein (LDL)‐ (r=-0.005, p=0.932) and high density lipoprotein (HDL)‐cholesterol (r=0.065, p=0.276) [74]. Interestingly, hypothesis was proposed ten years ago stating the possibility that statins could be the analogues of VitD, acting via same receptors, particularly when we are talking about their mutual effect of enhancement of immune competence [78]. So, it seems that this absence of association between VitD status and parameters of cholesterol metabolism made this hypothesis shaky to some extent.
\nAnother component of MetS for which association with VitD status has not been unequivocally confirmed is hypertension. Variability of blood pressure driven by the seasons or latitude speaks for the existence of this association, as well as the results of experimental studies pointing to VitD as an inhibitor of the renin‐angiotensin‐aldosterone axis [79, 80]. Negative correlation between VitD concentrations and blood pressure was demonstrated in most but not all of the surveys. This negative association was stronger in subjects younger than 50 years [81–83], while the absence of any relationship between VitD status and hypertension was also registered in some of the trials [74, 76, 84, 85], particularly those conducted in older subjects [84, 85]. However, in postmenopausal women with the VitD concentrations in the lowest quartiles corresponding to its severe deficiency, odds ratio (OR) for hypertension was 1.81 (95% CI: 1.15–2.85) [77].
\nAlthough APS represents acquired, autoimmune condition, its pathophysiology and, especially pathophysiology of thrombosis in APS is highly heterogeneous, involving different genes and acquired factors [86], VitD insufficiency/deficiency being among them.
\nSame as for relationship between MetS and APS, much more is known about the impact of VitD status on antiphospholipid syndrome, associated with autoimmune rheumatic diseases, than on primary antiphospholipid syndrome. Patients with PAPS represent the population of particular interest for the investigation of interrelations with components of MetS and/or VitD status since these patients, unlike those with sAPS, were not treated with drugs (i.e. corticosteroids, immunosuppressants) which may affect expression of most of the MetS characteristics as well as VitD level.
\nOne of the first announcements on the prevalence of VitD insufficiency or deficiency in PAPS and their impact on its manifestations dated from 2010 [87]. This letter to the editor presented the results of research conducted by Brazilian investigators in the group of forty‐six PAPS patients, younger than 60 years, in whom the VitD levels were assessed in the autumn, when it was expected to be highest. VitD deficiency was found in 11% and insufficiency in 74% of these PAPS patients, resembling the findings of Italian authors [88] which have reported the prevalence of VitD deficiency in 17% and insufficiency in 60% of PAPS patients. It is interesting that Brazilian authors have noticed that VitD insufficient PAPS patients tended to be more overweighed than those with adequate VitD level [87]. Also, it seems that thrombotic APS is characterized with significantly lower concentrations of VitD than purely obstetric clinical syndrome (20.8 vs. 33.3 ng/ml, p<0.01) [88] highlighting once again the role of this vitamin in thrombosis. High prevalence of VitD deficiency among patients with APS (49.5%) and its significant correlation with thrombotic events were confirmed by Israeli authors [68]. In vitro, they have also demonstrated VitD ability to inhibit anti‐β2‐glycoprotein I autoantibody (anti‐β2‐GPI Ab)‐mediated TF expression [89].
\nSeasonal variations in VitD concentrations were demonstrated in PAPS patients same as in healthy controls, with preserved differences in its level between these two groups through all seasons [88, 90]. These differences were most pronounced during summer, while they were not statistically significant only during the spring. This observation was somewhat surprising, given the lack of banning from sun exposure in these patients. That sun avoidance is not a cause of highly prevalent VitD deficiency and insufficiency in PAPS patients was indirectly demonstrated in previous Italian studies [88, 90] by observed absence of any difference in VitD levels between antinuclear antibodies (ANA)‐positive and negative PAPS patients.
\nUntil now, there is no valid explanation for the probable cause‐and‐effect relationship between insufficient VitD level, on one side, and PAPS or sAPS, on the other. There are only assumptions, and even they are much better clarified for sAPS [91–93], especially that accompanying SLE [91, 94, 95]. It is obvious that low levels of vitamin D in sAPS could not be attributed purely to banning of sun exposure or the use of certain medication in these patients. In an Israeli and European cohort of patients with SLE, significant negative correlation (r=-0.12, p=0.018) was demonstrated between the serum VitD concentrations and disease activity, assessed by SLE disease activity‐2000 (SLEDAI‐2K) and European Consensus Lupus Activity Measurement (ECLAM), which were converted into standardized z‐value [94]. Severe VitD deficiency was found in 17.89% of 123 SLE patients with short disease duration, while the presence of renal disease (OR 13.3, 95% CI 2.3–76.7, p<0.01) and photosensitivity (OR 12.9, 95% CI 2.2–75.5, p<0.01) were its strongest predictors [95]. Investigation conducted in a small group of young women with newly diagnosed SLE, from one of the sunny places in Iran, gave very interesting results. VitD deficiency was highly prevalent among these patients, mild in 12.5%, moderate in 62.5% and severe in 17.5% of them [96]. It was much more pronounced in them than in general population of the similar age in that region, in whom mild VitD was present in 15.5%, moderate in 47.1% and severe in 7.1%. Very interesting was also an observation that serum VitD concentrations showed significant negative correlation with another disease activity score, the British Isles Lupus Assessment Group (BILAG) (r=-0.486, p=0.001), in spite of the short duration of disease [97]. Hypothetical explanation for the low serum concentrations of VitD in SLE patients by the existence of inhibiting anti‐VitD antibodies in circulation could not be confirmed by the literature data [97, 98]. Their existence could be proven in 4–6% of patients with SLE and 3.5% of APS patients. Its association with anti‐dsDNA (p=0.0004) could point to its potential role in this condition, but being only one of 116 different antibodies present in SLE patients characterized by the polyclonal B lymphocyte activation, it is still uncertain if it is pathogenic [97]. It seems that their presence did not affect VitD levels in these patients [97, 98], and it was speculated that they could be the consequence of high‐dose VitD consumption rather than the cause of this vitamin deficiency [99].
\nOnce again, it is important to emphasize that VitD deficiency is more pronounced in more severe APS phenotypes, i.e. thrombotic APS [88]. It could be speculated that supplementation of this vitamin in these very patients may have certain beneficial effects [88, 99], but there is still no prospective studies proving them. Hypothesis of statins as VitD analogues has not still been tested in well‐designed, randomized prospective trials [78]. However, since its proposal, there have been many experimental and small clinical studies confirming statins therapeutic value in APS patients, particularly in those with its thrombotic form [99–103]. So, future studies are badly needed to determine all the aspects of VitD repletion in APS prevention/therapy (choice between VitD precursors, its active form or VitD analogues, their dosage and treatment goals).
\nPrevalence of metabolic syndrome in APS, primary or associated with certain rheumatic diseases, is high.
Atherogenic dyslipidaemia is the most prevalent characteristic of metabolic syndrome in APS patients.
Prevalence of thrombotic events was significantly higher in APS patients with coexisting metabolic syndrome, compared with APS patients without metabolic syndrome characteristics.
Among APS patients, prevalence of vitamin D deficiency was significantly higher in patients with coexisting metabolic syndrome, compared with those without it.
Among APS patients, vitamin D level was also significantly lower in patients with previous thrombotic events than in those without them.
In the contemporary literature, there are much more data in favour of pathogenic than therapeutic role of vitamin D in thrombotic events characterizing APS and/or metabolic syndrome. So, prospective studies designed to test all the aspects of VitD repletion in prevention and/or therapy of thrombotic events in APS and/or metabolic syndrome are badly needed.
Elucidating interrelationships between vitamin D deficiency, metabolic syndrome phenotype and thrombotic events in APS patients open up the possibility of distinguishing those subjects with the particularly high cardiovascular risk and ensuing need for the strict control of modifiable risk factors and vitamin D supplementation.
\nBariatric surgery is the most effective option for individuals with severe obesity. It includes several surgical procedures, commonly divided into restrictive such as Laparoscopic Adjustable Gastric Banding, Banded Gastric Bypass, Sleeve Gastrectomy, malabsorptive such as Biliopancreatic Diversion, Intragastric Balloon, and mixed procedures such as Roux-en-Y- Gastric Bypass, Mini Gastric Bypass, and Gastric Bypass.
Bariatric surgery procedures lead to substantial weight loss and marked improvements in obesity-related comorbidities as well as quality of life. Nonetheless, there is a significant variation in long-term weight loss maintenance and weight regain has been partially attributed to psychological factors.
For these reasons, the pre-operative evaluation of the psychological conditions of the candidates for bariatric interventions is required in order to achieve the desired post-operative outcomes for a long time. In addition, adjunctive pre or post-operative psychosocial interventions are highly recommended for bariatric patients [1, 2] with psychological difficulties.
Within this chapter, the main components of pre-surgical psychological assessment for bariatric candidates will be discussed, including procedures and instruments involved. Moreover, an overview of the principal characteristics of pre/post-surgical psychological support will be provided.
Bariatric surgery has become a popular treatment option for the management of obesity. However, not every obese individual could be considered as a candidate for bariatric surgery. The National Institutes of Health (NIH) Consensus Development Conference Panel held in 1951 outlined criteria for patients considering for bariatric surgery:
BMI > 40 (obesity grade III); BMI > 35 (obesity grade II) with comorbidities; BMI > 30 (obesity grade I with uncontrolled Diabetes Mellitus type 2 and high cardiovascular risk)
Reported previous failure of nonsurgical weight-loss efforts
Absence of medical or psychological contraindications
Being well-informed, motivated, and compliant
A pre-surgical evaluation of the candidates to bariatric surgery should be conducted in order to assess the presence of recommended criteria for surgery, and to identify and modify, when possible, any risk factors associated with undesired treatment outcomes that may reduce the long term-successful weight loss.
Within the pre-surgical evaluation, the psychological assessment of candidates for bariatric surgery is an essential component. The rationale for the evaluation for bariatric surgery candidates was based on collecting evidences suggesting the presence of a higher level of psychiatric disorders among obese patients than the normative population [3]. The principal goals of psychological pre-surgical evaluation are:
to identify any psychosocial contraindications to surgery and obstacles to post-operative success, or any psychosocial factor predicting previous weight gain prior to surgery;
to screen candidates who may benefit from a psychological treatment prior to surgery, in order to maximize long term bariatric outcomes and improve their quality of life;
to select patients who may need further psychological support after surgery;
to propose alternative treatment when patients do not meet the criteria for bariatric surgery [4].
According to a recent systematic review [5] about one-third of bariatric surgery candidates present a psychological disturbance, such as depression and anxiety and there is a high prevalence of Binge Eating Disorder [6]. Other mental health conditions related to bariatric candidates are psychosis, PTSD substance abuse and personality disorders.
Although the prevalence of mental health conditions among bariatric patients is higher than in the normative population, there is no clear evidence that pre-operative mental health conditions are associated with poorer post-operative weight loss [7]. Nevertheless, prospective studies showed that pre-operative depression and anxiety predict poorer outcomes after surgery [6].
Unfortunately, long term successful weight loss could be less than optimal, and partially depends on the individual’s ability to implement consistent lifestyle changes. For these reasons the psychological evaluation of bariatric surgery candidates is requested for monitoring and addressing psychological factors pre-and-post surgery.
In a recent review [8] aimed to explore the present practices adopted by clinics to assess bariatric candidates, it has been highlighted that, in many cases, the presence of uncontrolled symptoms of schizophrenia, drug and alcohol abuse, mental retardation and lack of knowledge about surgery are considered contraindications to surgical approval. Other factors that most frequently are considered limitations to surgery include the presence of symptoms of bipolar disorder and history of suicide attempts, lack of compliance to medical recommendations, unrealistic expectation to surgery outcome, while the age of patients as well as the lack of social support are often considered no-contraindication to surgery. Possible contraindications that could represent a limitation to surgery are past criminal behaviors, the presence of eating disorders, and the inability to follow a diet over time. Finally, according to the programs included in the study, binge eating disorder, depression, obsessive–compulsive disorder, tobacco use, and history of sexual abuse are considered definite or possible contraindication to surgery.
Although the relevance of the psychological assessment for bariatric surgery candidates was recognized for a long time, currently no evidence-based guidelines are available [9, 10].
According to the most commonly used practices in surgery clinics, the evaluation of candidates for bariatric surgery comprises a medical chart review, a comprehensive clinical interview, and psychological testing [11]. Moreover, the psychological assessment should be part of a multidisciplinary approach aimed to carefully assess risks and benefits for the patients related to surgery.
Clinical interviews are commonly used in bariatric centers. During the interview, several areas of interests should be properly investigated:
Patient’s understanding of the surgery
Patients seeking bariatric surgery are required to have adequate knowledge about the surgery procedures, including which are the potential risks associated with surgery, as well as the lifelong behavioral change that must occur for achieving expected results. For these reasons, during the presurgical psychological evaluation, it is important to know which are the patient’s expectation to surgery and assess their willingness to engage themselves in a stable lifestyle behavioral change.
Eating behaviors
Among the obese population, there is a high prevalence of individuals with comorbid Binge Eating Disorder (BED), mainly characterized by frequent episodes of binge eating in the absence of following compensatory strategies such as vomiting or purging. Other common eating disorders are Bulimia Nervosa (BN) and Night Eating Syndrome (NES). BM refers to recurrent binge episodes associated with compensatory extreme weight-control behaviors such as vomiting, purging, strict dieting, excessive physical activity. NES consists of morning anorexia, evening hyperphagia, and insomnia. Patients with an eating disorder need to understand that surgery alone cannot modify their problematic eating behaviors, but further efforts in changing their lifestyle behaviors related to eating and physical activity are required in order to achieve lifelong weight loss.
Psychiatric conditions
Any previous or current psychiatric disturbance should be addressed during the pre-surgical assessment. The evaluation for psychiatric disorders is aimed to identify symptoms of depression, anxiety, mania, psychosis, suicidal ideation, substance abuse, history of abuse or familial history of mental health problems and previous treatment experienced. Diverse opinions exist about the influence of psychiatric disturbances on surgery outcomes. According to some authors, the presence of one or more mentioned psychiatric disturbances alone is not a contraindication for bariatric surgery. However, it is important to evaluate the severity of symptomatology and, if necessary, referring patients for additional psychological support previous to surgery. Other authors suggest that the presence of uncontrolled eating, current substance abuse, poor adherence to recommendation, psychosis, severe mood disorders, major life stressors should be considered as contraindications to bariatric surgery [12, 13].
Social support
Given the impact that surgery will have not only on their lives but also on the environment where patients live, during the psychological assessment clinicians should explore the familial and the social context that surrounds patients. Candidates should be asked to describe the people who live with them, their opinion relative to bariatric surgery decision and whether their family will help them after surgery. Patients should be informed about the possible social consequences that may occur after surgery.
There is an availability of templates for conducting interviews that help clinicians to assess the domains of interest.
The Weight and Lifestyle Inventory [14] is designed to assess the eating and physical activity habits, the psychological status and the presence of stressful life events.
The Boston Interview [15] aims to assess weight, diet, and nutrition history, dysfunctional eating, medical condition, understanding of surgical procedures, concerns and benefits, motivation for surgery, interpersonal functioning, and psychiatric conditions.
While clinical interviews are widely used in clinical settings, only a few clinics employ some forms of objective tests. The use of psychological instruments allows clinicians to collect more information, in a rapid but precise validated and empirical way than clinical interviews alone. Some broadband instruments provide a broad assessment of patients, across several psychological domains, including emotional, cognitive and behavioral ones. Unfortunately, broadband instruments cannot provide information about specific content areas, such as eating disorders, and require costs for administration. To overcome these limitations, clinicians can administer narrowband instruments that provide a good solution to assess specific domains. In addition, narrowband instruments are more feasible and can be administered quickly. Below is the description of the most frequently used broadband and narrowband instruments for the psychological evaluation of bariatric candidates.
Minnesota Multiphasic Personality Inventory (MMPI-2; [16]) is the most widely used instruments for the assessment of surgery candidates. It consists of 587 items and it can be administered in two hours approximately, while the newer version, MMPI-2 Restructured Form (MMPI-2 RF; [17]) is composed of 338 items and the time for administration is 35–50 minutes. MMPI-2 RF allows clinicians to assess the global functioning of patients, including thoughts emotions and behaviors. The test allows also to detect cognitive, interpersonal, and somatic problems.
Symptom Item Checklist–90 –Revised (SCL–90 –R; [18]). The SCL-90 –R is widely used to assess the global psychological distress by exploring nine dimensions: somatization, depression, anxiety, phobic anxiety, obsessive–compulsive, interpersonal sensitivity, hostility, psychoticism, and paranoid ideation. The higher scores reflect higher distress. It is composed of Likert scale-90 items in which symptoms are presented and patients are asked to report how many times they experienced each symptom in the past 7 days.
Beck Depression Inventory-II (BDI-II; [19]) is a self-report measure composed of 21 items assessing the presence of depressive symptoms.
Beck Anxiety Inventory (BAI; [20]). is a self-report measure composed of 21 items assessing the presence of anxiety symptoms.
Binge Eating Scale (BES; [21]). It is one of the most common instruments used among the bariatric population. It is composed of 16 self-report items assessing binge eating severity.
The Eating Disorders Inventory–III (EDI-III; [22]); It consists of 91 items related to 11 subscales: bulimia, thinness, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, maturity fears, asceticism, impulse regulation, and social insecurity.
Below, a table to describe the most widely used tests is presented in Table 1.
Number of item | Time for administration | Subscales/Key areas | |
---|---|---|---|
Personality assessment | |||
MMPI 2 | 567 | 90–120 min | Response attitudes, mental health symptoms, personality traits, and special problems 10 clinical scales and 6 validity scales. Domains: personality traits, mental health symptoms, special problems, response attitudes |
MMPI-2-RF | 338 | 35–50 min | 42 substantive scales and 9 validity scales. Domains: problems, interests, personality psychopathology |
SCL-90-R | 90 | 12–15 min | Global psychological distress. 9 Scales: somatization, obsessive–compulsive, interpersonal sensitivity, depression, anxiety, anger/hostility, phobic anxiety, paranoid ideation, psychoticism |
PAI | 344 | 50–60 min | 11 clinical scales assessing psychopathology in three spectrums: neurotic, psychotic, and behavioral/impulse control; 5 Treatment scales assessing risk for self-harm or harm to others, how patients respond to environmental factors, and motivation for treatment; 2 interpersonal scales assessing warm/affiliative versus cold/rejecting and dominating/controlling versus submissive; 4 validity scales |
MBMD | 165 | 20–25 min | 32 clinical scales and 5 validity scales. Domains: response patterns, negative health habits, psychiatric indications, coping styles, and stress moderators |
MCMI-III | 175 | 25–30 min | 14 personality disorders; 10 clinical syndromes; 5 validity scales |
BPI | 240 | 35 min | 12 clinical scales: Hypochondriasis, Depression, Denial, Interpersonal Problems, Alienation, Persecutory Ideas, Anxiety, Thinking Disorder, Impulse Expression, Social Introversion, Self-Depreciation, and Deviation; 2 validity scales |
Eating disorders | |||
EDI-3 | 91 | 20 min | 11 subscales: drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, maturity fears, asceticism, impulse regulation, and social insecurity |
EDE-Q | 32 | 5–10 min | Eating behaviors. Subscales: restraint, eating concern, weight concern, and shape concern |
QEWP | 28 | 5 min | Binge eating patterns |
TFEQ | 51 | 20 min | Cognitive and behavioral components of eating. 3 scales: restraint, hunger, and disinhibition |
BES | 16 | 5 min | Symptoms of Binge Eating |
NEQ | 14 | 5–10 min | Symptoms of night eating syndrome. 4 scales: nocturnal ingestion, evening hyperphagia, morning anorexic, and mood/sleep |
Mood Disturbances | |||
BDI-II | 21 | 5–10 min | Symptomps of depression |
BAI | 21 | 5–10 min | Symptoms of anxiety |
PHQ-9 | 9 | 5 min | Symptoms of depression |
CES-D | 20 | 10 min | Symptoms of depression |
MDQ | 13 | 5 min | Bipolar symptoms |
GAD-7 | 7 | 5 min | Symptoms of anxiety |
Substance abuse | |||
AUDIT | 10 | 5 min | Drinking patterns |
MAST | 25 | 5–10 min | Alchool abuse and related problems |
SASSI-3 | 93 | 20 min | Substance abuse. 8 subscales: symptoms of substance misuse, obvious attributes, subtle attributes, defensiveness, supplemental addiction measure, family versus control subjects, correctional, and random answering pattern |
Quality of life | |||
IWQL | 74 | 15 min | 8 domains: health, social/interpersonal life, work, mobility, self-esteem, sexual life, activities of daily living, comfort with food |
Cognitive development | |||
MMSE | 30 | 10 min | Cognitive impairment. Domains: orientation, attention, registration, recall, language, repetition, complex commands. |
Physical conditions | |||
MBHI | 150 | 20 min | Personality and Coping style among people with physical pathologies. 8 coping style scales; six psychogenic attitudes; 3 psychosomatic correlate scales; 3 risk for poorer outcomes scales. |
Principal used psychometric instruments for the assessment of bariatric candidates.
Abbreviations: MMPI-2; Minnesota Multiphasic Personality Inventory 2; MMPI-2-RF: Minnestota Multiphasic Personality Inventory-2-Revised Form; SCL-90-R: Symptom Check-List-90-Revised; PAI: Personality Assessment Inventory; MBMD: Millon Behavioral Medicine Diagnostic; MCMI-III: Millon Clinical Multiaxial Inventory; BPI: Basic Personality Inventory; EDI-3: Eating Disorders Inventory; EDE-Q: Eating Disorder Examination-Questionnaire; QEWP: Questionnaire of Eating and Weight Patterns–Revised; TFEQ: The Three-Factor Eating Questionnaire; BES: Binge Eating Scale; NEQ: Night eating Questionnaire; BDI-III: Beck Depression inventory; BAI: Beck Anxiety Inventory; PHQ-9: The Patient Health Questionnaire-9; CES-D: Center for Epidemiologic Studies Depression Scale; MDQ: Mood Disorders Questionnaire; GAD-7: Generalized Anxiety Disorder-7; AUDIT: Alcohol Use Disorders Identification Test; MAST: Michigan Alcoholism Screening Test; SASSI-3: Substance Abuse Subtle Screening Inventory-3; IWQOL: Impact of Weight on Quality of Life; MMSE: Mini-Mental State Evaluation; MBHI: Millon Behavioral Health Inventory.
Bariatric surgery is the most effective intervention for weight loss in the field of obesity management. Unfortunately, patients often do not achieve optimal results in term of weight loss maintenance over time and meet various difficulties related to eating behaviors and psychological functioning. Given the significant variation in weight long-term outcomes after surgery that could be partially attributed to a number of risk factors, including psychological factors, psychological pre-operative or post-operative interventions are increasingly being recommended for patients seeking or undergoing bariatric surgery [23].
The most delivered psychological interventions included Cognitive Behavioral Therapy (CBT) but promising evidence suggests the effectiveness of intervention based on Acceptance and Commitment Therapy (ACT) and Dialectical Behavioral Therapy (DBT).
Cognitive behavioral interventions typically include psychoeducation, goal setting, self-monitoring, stimulus control, problem solving, and reinforcement, for the promotion of lifestyle-related behavior change. Through the psychological intervention, patients are encouraged to recognize their problematic eating behaviors, learn strategies to cope with life stressors, and engage themselves in healthy eating behaviors and physical activity. Recently, David and colleagues [5] conducted a systematic review aimed to examine the effectiveness of cognitive behavioral interventions. Results showed that the most common techniques employed during the interventions were psychoeducation, self-monitoring, goal setting, stimulus control, cognitive restructuring, problem solving and reinforcement, as well as addressing ambivalence, improving self-care and prevention of relapse. Most of the interventions included in the study were delivered in person, or in combination with telephone or web. With respect to intervention outcomes, the main findings of the review revealed that 32% of included studies showed a significant impact on weight loss. Specifically, it seems that the higher impact on weight loss was found in post-operative intervention, than the benefits of pre-operative interventions which were not maintained at follow-up. Other interventions outcomes were lifestyle behaviors, eating pathology, and psychological functioning. Results showed that psychological interventions seem to have an inconsistent influence on change in dietary habits and physical activity, but a limited number of studies examined this outcome. With respect to eating pathology, psychological interventions included in the study revealed a significant impact on reducing binge eating and emotional eating. Similarly, interventions had a positive impact on psychological functioning. Both pre-operative and post-operative interventions improved quality of life and reduced depression and anxiety symptoms.
Recently, other forms of psychological interventions were applied to bariatric patients. In a pilot RCT, Weineland and colleagues [24] compared an intervention based on ACT (two face to face session in combination with internet-based support) to usual treatment. Results showed that patients in the ACT condition significantly improved in eating disorders, body dissatisfaction, quality of life, and acceptance of thoughts and feelings related to weight.
Promising results were also obtained in an observational study [25] in which a pre-operative intervention based on DBT skills training combined with treatment as usual compared to a treatment as usual group. The intervention of DBT was focused on regulating emotions with emotion regulation, mindfulness, distress tolerance, and interpersonal effectiveness training. The results offered preliminary evidence in support of the effectiveness of a brief DBT skills training intervention in combination with treatment as usual in reducing eating pathology (binge eating and emotional eating).
Bariatric surgery has been demonstrated to be a valid solution for the treatment of obesity. It is recommended for well-motivated and informed patients with severe obesity or obesity with related comorbidities. Approximately, all bariatric surgery procedures are effective in producing weight loss and related substantial improvements in health conditions [26, 27, 28].
Candidates for bariatric surgery require not only a multidisciplinary pre-operative screening, which is aimed to prepare and educate patients for the lifestyle changes required after surgery, but also would benefit from a supportive, integrated additional psychological interventions aimed to maximize weight loss and weight loss maintenance after surgery. Particularly, weight loss is not the primary goal of psychological interventions. In fact, findings indicate that the pre-operative interventions do not have a significant effect on weight loss [29]. Rather, they should be considered an option for patients to overcome their difficulties, reduce pre-existing symptomatology, and improving in their eating behaviors and lifestyle. On the contrary, psychological post-operative interventions have been associated with significant weight loss and currently they are the most promising approach to improve the outcomes of bariatric surgery.
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