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Pilot Clinical Trial of Time-Restricted Eating in Patients with Metabolic Syndrome.
Świątkiewicz, I, Mila-Kierzenkowska, C, Woźniak, A, Szewczyk-Golec, K, Nuszkiewicz, J, Wróblewska, J, Rajewski, P, Eussen, SJPM, Færch, K, Manoogian, ENC, et al
Nutrients. 2021;(2)
Abstract
Metabolic syndrome (MetS) and erratic eating patterns are associated with circadian rhythm disruption which contributes to an increased cardiometabolic risks. Restricting eating period (time-restricted eating, TRE) can restore robust circadian rhythms and improve cardiometabolic health. We describe a protocol of the Time-Restricted Eating on Metabolic and Neuroendocrine homeostasis, Inflammation, and Oxidative Stress (TREMNIOS) pilot clinical trial in Polish adult patients with MetS and eating period of ≥14 h/day. The study aims to test the feasibility of TRE intervention and methodology for evaluating its efficacy for improving metabolic, neuroendocrine, inflammatory, oxidative stress and cardiac biomarkers, and daily rhythms of behavior for such population. Participants will apply 10-h TRE over a 12-week monitored intervention followed by a 12-week self-directed intervention. Changes in eating window, body weight and composition, biomarkers, and rhythms of behavior will be evaluated. Dietary intake, sleep, activity and wellbeing will be monitored with the myCircadianClock application and questionnaires. Adherence to TRE defined as the proportion of days recorded with app during the monitored intervention in which participants satisfied 10-h TRE is the primary outcome. TREMNIOS will also provide an exploratory framework to depict post-TRE changes in cardiometabolic outcomes and behavior rhythms. This protocol extends previous TRE-related protocols by targeting European population with diagnosed MetS and including long-term intervention, validated tools for monitoring dietary intake and adherence, and comprehensive range of biomarkers. TREMNIOS trial will lay the groundwork for a large-scale randomized controlled trial to determine TRE efficacy for improving cardiometabolic health in MetS population.
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Predicting Metabolic Syndrome Using Anthropometric Indices among Chinese Adolescents with Different Nutritional Status: A Multicenter Cross-sectional Study.
Li, YM, Zou, ZY, Ma, YH, Luo, JY, Jing, J, Zhang, X, Luo, CY, Wang, H, Zhao, HP, Pan, H, et al
Biomedical and environmental sciences : BES. 2021;(9):673-682
Abstract
OBJECTIVE To evaluate the predictive performance of anthropometric indices for metabolic syndrome (MetS) among Chinese adolescents with different nutritional status. METHODS We recruited 9,513 adolescents aged 10-18 years from seven provinces in China during September 2014. Anthropometric indices and blood pressure were measured at recruitment, and blood samples were collected for determining fasting plasma glucose and lipid profile. Receiver operating characteristic (ROC) analyses were used to assess the predictive performance of anthropometric indices, including body mass index (BMI) percentile, waist circumference percentile, waist-height ratio, and waist-hip ratio. RESULTS Overall, the four anthropometric indices showed good accuracy for predicting MetS with areas under ROC curves (AUCs) ranging from 0.86 to 0.94; similar AUCs ranging from 0.73 to 0.99 were observed for participants with normal weight. The performance of all four indices was poor in overweight and obese participants, with AUCs ranging from 0.66 to 0.77 and from 0.60 to 0.67, respectively. Waist circumference showed relatively better performance in all the subgroup analyses. CONCLUSIONS We suggest using anthropometric indices with the cutoff values presented here for predicting MetS in the overall and normal-weight adolescent population, but not in the overweight and obese adolescent population where more specific screening tests are required.
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Effects of a psychosocial intervention at one-year follow-up in a PREDIMED-plus sample with obesity and metabolic syndrome.
Mallorquí-Bagué, N, Lozano-Madrid, M, Vintró-Alcaraz, C, Forcano, L, Díaz-López, A, Galera, A, Fernández-Carrión, R, Granero, R, Jiménez-Murcia, S, Corella, D, et al
Scientific reports. 2021;(1):9144
Abstract
This study examines if overweight/obesity are related to higher impulsivity, food addiction and depressive symptoms, and if these variables could be modified after 1 year of a multimodal intervention (diet, physical activity, psychosocial support). 342 adults (55-75 years) with overweight/obesity and metabolic syndrome (MetS) from the PREDIMED-Plus Cognition study were randomized to the intervention or to the control group (lifestyle recommendations). Cognitive and psychopathological assessments were performed at baseline and after 1-year follow-up. At baseline, higher impulsivity was linked to higher food addiction and depressive symptoms, but not to body mass index (BMI). Food addiction not only predicted higher BMI and depressive symptoms, but also achieved a mediational role between impulsivity and BMI/depressive symptoms. After 1 year, patients in both groups reported significant decreases in BMI, food addiction and impulsivity. BMI reduction and impulsivity improvements were higher in the intervention group. Higher BMI decrease was achieved in individuals with lower impulsivity. Higher scores in food addiction were also related to greater post-treatment impulsivity. To conclude, overweight/obesity are related to higher impulsivity, food addiction and depressive symptoms in mid/old age individuals with MetS. Our results also highlight the modifiable nature of the studied variables and the interest of promoting multimodal interventions within this population.
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Metabolic syndrome in obesity: treatment success and adverse pregnancy outcomes with ovulation induction in polycystic ovary syndrome.
Arya, S, Hansen, KR, Peck, JD, Wild, RA, ,
American journal of obstetrics and gynecology. 2021;(3):280.e1-280.e11
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BACKGROUND Obesity is common in women with polycystic ovary syndrome. polycystic ovary syndrome and obesity are associated with reduced fertility. The effect of metabolic syndrome on the success of infertility treatment and pregnancy outcomes in women with polycystic ovary syndrome undergoing ovulation induction has not been investigated. OBJECTIVE The objectives of this study were to determine the associations of metabolic syndrome on the rate of live birth after ovulation induction and pregnancy complications in obese women with polycystic ovary syndrome and determine whether there is a difference in outcomes concerning specific medications used for ovulation induction. STUDY DESIGN This prospective cohort analysis used data collected from participants in the Pregnancy in Polycystic Ovary Syndrome II clinical trial conducted by the Reproductive Medicine Network. In the Pregnancy in Polycystic Ovary Syndrome II trial, 750 women with polycystic ovary syndrome and infertility were randomized to either clomiphene citrate or letrozole for ovulation induction for 1 to 5 cycles or until pregnancy occurred. Cox regression and modified Poisson regression, chi-square test, and Student t test or Wilcoxon test were used in this study. Outcomes of interest were rates of live birth and clinical pregnancy and pregnancy complications. Having metabolic syndrome was defined by the presence of at least 3 of 5 cardiometabolic risk factors (waist circumference of >88 cm, low high-density lipoprotein cholesterol of <50 mg/dL, triglycerides of ≥150 mg/dL, systolic blood pressure of ≥130 or diastolic blood pressure of ≥85 mm Hg, and fasting glucose of >100 mg/dL). In addition, we used a continuous metabolic syndrome z score. Body mass index categories were defined as normal (body mass index of <25 kg/m2), high (25 to 35 kg/m2), and very high (>35 kg/m2). RESULTS As illustrated in the Table, early pregnancy losses showed no difference by metabolic syndrome. Fewer women achieved a clinical pregnancy (20.5% vs 29.7%; P=.007) or had a live birth (16.5% vs 27%; P=.001) in the presence of metabolic syndrome. Early pregnancy losses showed no difference by metabolic syndrome status. However, at least 1 pregnancy complication occurred more often with metabolic syndrome: 61.9% (26 of 42 cases) with metabolic syndrome vs 44.4% (59 of 133 cases) (P=.05) without metabolic syndrome. Gestational diabetes mellitus (35.7% vs 18.2%; P=.02) and macrosomia (21.4% vs 8.3%; P=.02) were more common in the presence of metabolic syndrome. After adjustment for other potential confounders, the rate ratio for live births for a 1-unit change in the metabolic syndrome z score was 0.89 (95% confidence interval, 0.79-1.00; P=.04) for those whose body mass index was 25 to 35 kg/m2. For the very high body mass index subgroup (>35 kg/m2), the independent effects of metabolic syndrome from obesity were harder to discern. The rate of live birth was higher with the use of letrozole, although metabolic syndrome had a different detrimental effect concerning the medication given. The overall incidence of pregnancy complications was high (approximately 49%) in the Pregnancy in Polycystic Ovary Syndrome II trial and the 2 medications. Letrozole was associated with more obstetrical complications in the presence of metabolic syndrome, and clomiphene was associated with a lower rate of live birth rate when metabolic syndrome was present. CONCLUSION Metabolic syndrome is a risk factor that lowers the rate of live birth after ovulation for women with polycystic ovary syndrome, independent of obesity, and it is particularly associated with a lower rate of live birth for women using clomiphene compared with women using letrozole. In addition, metabolic syndrome is a risk factor for pregnancy complications for women with obesity using letrozole. Furthermore, having metabolic syndrome is a risk factor for gestational diabetes mellitus and macrosomia.
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Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB).
Caiazzo, R, Branche, J, Raverdy, V, Czernichow, S, Carette, C, Robert, M, Disse, E, Barthet, M, Cariou, B, Msika, S, et al
Annals of surgery. 2020;(5):696-702
Abstract
OBJECTIVE The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS). SUMMARY BACKGROUND DATA DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study. METHODS We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed. RESULTS A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%. CONCLUSIONS The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.
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Diet quality and nutrient density in subjects with metabolic syndrome: Influence of socioeconomic status and lifestyle factors. A cross-sectional assessment in the PREDIMED-Plus study.
Cano-Ibáñez, N, Gea, A, Ruiz-Canela, M, Corella, D, Salas-Salvadó, J, Schröder, H, Navarrete-Muñoz, EM, Romaguera, D, Martínez, JA, Barón-López, FJ, et al
Clinical nutrition (Edinburgh, Scotland). 2020;(4):1161-1173
Abstract
BACKGROUND Socioeconomic disparities and lifestyle factors are likely to determine the overall quality of the diet. In addition, overeating is compatible with inadequate micronutrient intake and it can lead to adverse health outcomes. OBJECTIVE To assess adequacy of dietary nutrient intake and to investigate the influence of socioeconomic and lifestyle factors on nutrient density in a large primary cardiovascular prevention trial conducted in healthy participants with metabolic syndrome (MetS) to assess the cardiovascular effects of an energy-restricted Mediterranean diet (PREDIMED-Plus). METHODS Baseline cross-sectional analysis of the PREDIMED-Plus trial with 6646 Spanish participants (aged 55-75 years in men and 60-75 years in women) with overweight/obesity and MetS. Energy and nutrient intake (for 10 nutrients) were calculated using a validated 143-item Food Frequency Questionnaire (FFQ) and nutrient density was estimated dividing the absolute nutrient intake by total energy intake. The prevalence of inadequate intake was estimated according to dietary reference intakes. Multivariable linear regression models were fitted to examine associations between socioeconomic status or lifestyle factors and nutrient density. RESULTS A considerable proportion of the screened participants showed a deficient intake of vitamins A, D, E, B9, calcium, magnesium and dietary fibre. Inadequate intake of four or more of the ten nutrients considered was present in 17% of participants. A higher nutrient density was directly and significantly associated with female sex, higher educational level and a better adherence to the Mediterranean diet. Lifestyle factors such as non-smoking and avoidance of sedentary lifestyles were also independently associated with better nutrient density. CONCLUSIONS Patients with MetS, despite being overweight, exhibited suboptimal nutrient intake, especially among men. Low nutrient density diet can be largely explained by differences in socioeconomic and lifestyle factors. These results highlight the importance of focussing on nutritional education in vulnerable populations, taking into account nutrient requirements.
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Common genetic variation in obesity, lipid transfer genes and risk of Metabolic Syndrome: Results from IDEFICS/I.Family study and meta-analysis.
Nagrani, R, Foraita, R, Gianfagna, F, Iacoviello, L, Marild, S, Michels, N, Molnár, D, Moreno, L, Russo, P, Veidebaum, T, et al
Scientific reports. 2020;(1):7189
Abstract
As the prevalence of metabolic syndrome (MetS) in children and young adults is increasing, a better understanding of genetics that underlie MetS will provide critical insights into the origin of the disease. We examined associations of common genetic variants and repeated MetS score from early childhood to adolescence in a pan-European, prospective IDEFICS/I.Family cohort study with baseline survey and follow-up examinations after two and six years. We tested associations in 3067 children using a linear mixed model and confirmed the results with meta-analysis of identified SNPs. With a stringent Bonferroni adjustment for multiple comparisons we obtained significant associations(p < 1.4 × 10-4) for 5 SNPs, which were in high LD (r2 > 0.85) in the 16q12.2 non-coding intronic chromosomal region of FTO gene with strongest association observed for rs8050136 (effect size(β) = 0.31, pWald = 1.52 × 10-5). We also observed a strong association of rs708272 in CETP with increased HDL (p = 5.63 × 10-40) and decreased TRG (p = 9.60 × 10-5) levels. These findings along with meta-analysis advance etiologic understanding of childhood MetS, highlighting that genetic predisposition to MetS is largely driven by genes of obesity and lipid metabolism. Inclusion of the associated genetic variants in polygenic scores for MetS may prove to be fundamental for identifying children and subsequently adults of the high-risk group to allow earlier targeted interventions.
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Metabolic Effects of 7 Antipsychotics on Patients With Schizophrenia: A Short-Term, Randomized, Open-Label, Multicenter, Pharmacologic Trial.
Zhang, Y, Wang, Q, Reynolds, GP, Yue, W, Deng, W, Yan, H, Tan, L, Wang, C, Yang, G, Lu, T, et al
The Journal of clinical psychiatry. 2020;(3)
Abstract
OBJECTIVE To compare longitudinal metabolic effects of 7 antipsychotics, including body mass index (BMI), waist circumference (WC), blood pressure (BP), glucose, triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C); to investigate risk factors for metabolic syndrome (MetS); and to make recommendations on frequency and timing of monitoring metabolic measurements. METHODS This randomized, open-label, pharmacologic trial was conducted among patients with schizophrenia (DSM-IV) in 32 hospitals across China. Patients were randomly assigned to 7 groups and assessed at baseline, 2, 4, and 6 weeks. Linear mixed-effect models were used to assess changes of metabolic measures over time. Multivariable logistic regression analysis was performed to investigate the risk factors for MetS. RESULTS In total, 2,550 (718 drug-naïve) of 2,774 patients finished the study between July 6, 2010, and November 30, 2011. We found significant (P < .05) changes for BMI, WC, TG, and LDL-C, with TG and LDL-C reaching a plateau. Interactions between baseline metabolic condition and changes over time were observed for BMI (χ² = 43.11, P < .001), WC (χ² = 36.34, P < .001), systolic BP (χ² = 11.92, P = .002), glucose (χ² = 6.09, P = .01), and TG (χ² = 6.01, P = .01). Antipsychotics generally had greater adverse effects on patients who were initially screened as metabolically normal. After controlling for other associated factors, we found that antipsychotics resulted in differing risk for incident MetS, with a similar pattern to findings in other populations: olanzapine (odds ratio [OR] = 3.36, P < .001) > quetiapine (OR = 3.29, P < .001) > perphenazine (OR = 2.73, P = .007) > risperidone (OR = 2.21, P = .02) > aripiprazole (OR = 1.74, P = .15) ≈ haloperidol (OR = 1.75, P = .22) ≈ ziprasidone (OR = 1, reference). CONCLUSIONS Metabolic traits should be monitored frequently in early stages of antipsychotic treatment due to rapid and substantial changes. Clinicians should not assume low risk for patients with normal metabolic parameters at baseline. TRIAL REGISTRATION Chinese Clinical Trial Registry identifier: ChiCTR-TRC-10000934.
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Development of a lifestyle intervention for the metabolic syndrome: Discovery through proof-of-concept.
Powell, LH, Appelhans, BM, Ventrelle, J, Karavolos, K, March, ML, Ong, JC, Fitzpatrick, SL, Normand, P, Dawar, R, Kazlauskaite, R
Health psychology : official journal of the Division of Health Psychology, American Psychological Association. 2018;(10):929-939
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OBJECTIVE The aim was to describe the early phases of the progressive development of a lifestyle treatment for sustained remission of the metabolic syndrome (MetS) using the Obesity-Related Behavioral Intervention Trials (ORBIT) model for behavioral treatment development as a guide. METHODS Early discovery and design phases produced a 3-component (diet, physical activity, stress), group-based lifestyle treatment with an intensive 6-month phase followed by monthly, participant-led maintenance meetings. In the proof-of-concept phase, 26 participants with the MetS (age 53 ± 7 years, 77% female, and 65% ethnic minority) were recruited in a quasi-experimental design to determine if treatment could achieve the prespecified benchmark of MetS remission in ≥50% at 2.5 years. Exploratory outcomes focused on MetS components, weight, and patient-centered benefits on energy/vitality and psychosocial status. RESULTS MetS remission was achieved in 53.8% after a median of 2.5 years. At 2.5 years, an increase of +15.4% reported eating ≥3 servings of vegetables/day, +7.7% engaged in ≥150 minutes of moderate-to-vigorous physical activity/week; and +11.5% reported experiencing no depression in the past 2 weeks. Weight loss ≥5% was achieved by 38.5%, and energy/vitality, negative affect, and social support improved. Median group attendance over 2.5 years was 73.8%. CONCLUSIONS It is plausible that this lifestyle program can produce a remission in the MetS, sustained through 2.5 years. After refinements to enhance precision and strength, progression to feasibility pilot testing and a randomized clinical trial will determine its efficacy as a cost-effective lifestyle option for managing the MetS in the current health care system. (PsycINFO Database Record
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Diets Low in Saturated Fat with Different Unsaturated Fatty Acid Profiles Similarly Increase Serum-Mediated Cholesterol Efflux from THP-1 Macrophages in a Population with or at Risk for Metabolic Syndrome: The Canola Oil Multicenter Intervention Trial.
Liu, X, Garban, J, Jones, PJ, Vanden Heuvel, J, Lamarche, B, Jenkins, DJ, Connelly, PW, Couture, P, Pu, S, Fleming, JA, et al
The Journal of nutrition. 2018;(5):721-728
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BACKGROUND Cholesterol efflux plays an important role in preventing atherosclerosis progression. Vegetable oils with varying unsaturated fatty acid profiles favorably affect multiple cardiovascular disease risk factors; however, their effects on cholesterol efflux remain unclear. OBJECTIVE The objectives of this study were to examine the effects of diets low in saturated fatty acids (SFAs) with varying unsaturated fatty acid profiles on serum-mediated cholesterol efflux and its association with the plasma lipophilic index and central obesity. METHODS The present study is a randomized, crossover, controlled-feeding study. Participants [men: n = 50; women: n = 51; mean ± SE age: 49.5 ± 1.2 y; body mass index (in kg/m2): 29.4 ± 0.4] at risk for or with metabolic syndrome (MetS) were randomly assigned to 5 isocaloric diets containing the treatment oils: canola oil, high oleic acid-canola oil, DHA-enriched high oleic acid-canola oil, corn oil and safflower oil blend, and flax oil and safflower oil blend. These treatment oils were incorporated into smoothies that participants consumed 2 times/d. For a 3000-kcal diet, 60 g of treatment oil was required to provide 18% of total energy per day. Each diet period was 4 wk followed by a 2- to 4-wk washout period. We quantified cholesterol efflux capacity with a validated ex vivo high-throughput cholesterol efflux assay. Statistical analyses were performed with the use of the SAS mixed-model procedure. RESULTS The 5 diets increased serum-mediated cholesterol efflux capacity from THP-1 macrophages similarly by 39%, 34%, 55%, 49% and 51%, respectively, compared with baseline (P < 0.05 for all). Waist circumference and abdominal adiposity were negatively correlated with serum-mediated cholesterol efflux capacity (r = -0.25, P = 0.01, r = -0.33, P = 0.02, respectively). CONCLUSION Diets low in SFAs with different monounsaturated fatty acid and polyunsaturated fatty acid profiles improved serum-mediated cholesterol efflux capacity in individuals with or at risk for MetS. This mechanism may account, in part, for the cardiovascular disease benefits of diets low in SFAs and high in unsaturated fatty acids. Importantly, central obesity is inversely associated with cholesterol efflux capacity. This trial was registered at www.clinicaltrials.gov as NCT01351012.