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Lifestyle intervention based on exercise and behavioural counselling and its effect on physical and psychological health in outpatients with schizophrenia spectrum disorders. An exploratory, pragmatic randomized clinical trial.
Fernández-Abascal, B, Suárez-Pinilla, M, Cobo-Corrales, C, Crespo-Facorro, B, Suárez-Pinilla, P
Schizophrenia research. 2023;:256-268
Abstract
Patients with Schizophrenia Spectrum Disorders (SSD) often lead unhealthy lifestyles. This pragmatic trial evaluated the effectiveness of a lifestyle intervention, consisting of a 12-week aerobic exercise program and behavioural counselling, in SSD outpatients with metabolic syndrome (MetS). It also aimed to assess persistence of potential effects in a 24-month long-term follow-up. Effectiveness was measured in terms of a wide range of outcomes involving physical and psychological health, quality of life, physical activity and changes in motivation to exercise within the context of the self-determination theory. Our primary outcome was waist circumference change. Thirty-three out of 48 participants completed the study. No differences between groups were found in terms of BMI change or other metabolic parameters. However, the active group (AG) showed improvement regarding waist circumference, negative symptomatology and identified motivation to exercise during the study and follow-up. The AG exhibited changes toward a more active pattern of activity after intervention. Moreover, belonging to the AG was a significant predictor for achieving any degree of clinical improvement after 24-month follow-up. Combined interventions of exercise and behavioural counselling in SSD patients with MetS should be considered as an essential part of the integral treatment in the context of mental health services.
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Effects of liraglutide on visceral and ectopic fat in adults with overweight and obesity at high cardiovascular risk: a randomised, double-blind, placebo-controlled, clinical trial.
Neeland, IJ, Marso, SP, Ayers, CR, Lewis, B, Oslica, R, Francis, W, Rodder, S, Pandey, A, Joshi, PH
The lancet. Diabetes & endocrinology. 2021;(9):595-605
Abstract
BACKGROUND Visceral and ectopic fat are key drivers of adverse cardiometabolic outcomes in obesity. We aimed to evaluate the effects of injectable liraglutide 3·0 mg daily on body fat distribution in adults with overweight or obesity without type 2 diabetes at high cardiovascular disease risk. METHODS In this randomised, double-blind, placebo-controlled, phase 4, single centre trial, we enrolled community-dwelling adults, recruited from the University of Texas Southwestern Medical Center, with BMI of at least 30 kg/m2 or BMI of at least 27 kg/m2 with metabolic syndrome but without diabetes and randomly assigned them, in a 1:1 ratio, to 40 weeks of treatment with once-daily subcutaneous liraglutide 3·0 mg or placebo, in addition to a 500 kcal deficient diet and guideline-recommended physical activity counselling. The primary endpoint was percentage reduction in visceral adipose tissue (VAT) measured with MRI. All randomly assigned participants with a follow-up imaging assessment were included in efficacy analyses and all participants who received at least one dose of study drug were included in the safety analyses. The trial is registered on ClinicalTrials.gov: NCT03038620. FINDINGS Between July 20, 2017 and Feb 21, 2020 from 235 participants assessed for eligibility, 185 participants were randomly assigned (n=92 liraglutide, n=93 placebo) and 128 (n=73 liraglutide, n=55 placebo) were included in the final analysis (92% female participants, 37% Black participants, 24% Hispanic participants, mean age 50·2 years (SD 9·4), mean BMI 37·7 kg/m2). Mean change in VAT over median 36·2 weeks was -12·49% (SD 9·3%) with liraglutide compared with -1·63% (SD 12·3%) with placebo, estimated treatment difference -10·86% (95% CI -6·97 to -14·75, p<0·0001). Effects seemed consistent across subgroups of age, sex, race-ethnicity, BMI, and baseline prediabetes. The most frequently reported adverse events were gastrointestinal-related (43 [47%] of 92 with liraglutide and 12 [13%] of 93 with placebo) and upper respiratory tract infections (10 [11%] of 92 with liraglutide and 14 [15%] of 93 with placebo). INTERPRETATION In adults with overweight or obesity at high cardiovascular disease risk, once-daily liraglutide 3·0 mg plus lifestyle intervention significantly lowered visceral adipose tissue over 40 weeks of treatment. Visceral fat reduction may be one mechanism to explain the benefits seen on cardiovascular outcomes in previous trials with liraglutide among patients with type 2 diabetes. FUNDING NovoNordisk.
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Real world study of short term efficacy, safety, and tolerability of canagliflozin 100 mg initiation in type 2 diabetes mellitus patients during hot humid Indian summer.
Sanyal, D, Majumder, A, Ghosh, S, Pandit, K
Diabetes & metabolic syndrome. 2021;(1):385-389
Abstract
BACKGROUND AND AIM To assess short term (3 months) efficacy, safety, and tolerability of canagliflozin 100 mg among type 2 diabetes mellitus (T2DM) initiated during hot humid Indian summer. METHODS A prospective, observational, multi-center study of 300 T2DM patients with inadequate glycemic control (i.e., HbA1c of ≥6.5%) with or without other antihyperglycemic agents (AHA) were enrolled in the study in the month of March. The objective of the study was to assess the efficacy that is changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), blood pressure (BP), lipid profile, body mass index (BMI) and safety of canagliflozin with regards to genitourinary infection, fall, diabetic keto acidosis (DKA) episodes, blood ketone and beta-hydroxybutyrate levels. All patients were initiated on canagliflozin 100 mg once daily for 12 weeks, irrespective of background medications. RESULTS At 12 weeks, a significant reduction was observed in all the glycemic parameters,BMI, BP, total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C). However, a nonsignificant reduction in estimated glomerular filtration rate (eGFR) was observed at 12 weeks. A total of 9 adverse events were reported including 2 episodes of urinary tract infection (UTI) and 4 episodes of genital infection. The blood ketone, beta-hydroxybutyrate levels were found to be within normal limits and no episode of DKA was reported at 12 weeks. None of our patients had reported any volume depletion related adverse events viz. postural hypotension, giddiness etc. CONCLUSION Canagliflozin 100 mg can be safely initiated in type 2 diabetes patients during hot humid Indian summer, irrespective of background medications and is effective and well tolerated.
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Addition of oat bran reduces HDL-C and does not potentialize effect of a low-calorie diet on remission of metabolic syndrome: A pragmatic, randomized, controlled, open-label nutritional trial.
Leão, LSCS, Aquino, LA, Dias, JF, Koifman, RJ
Nutrition (Burbank, Los Angeles County, Calif.). 2019;:126-130
Abstract
OBJECTIVES It is unclear whether addition of soluble fiber to a low-calorie diet potentializes weight loss and amelioration of metabolic syndrome (MetS). The aim of this study was to analyze the effects of oat bran on prevalence of MetS and associated disorders. METHODS A pragmatic, randomized controlled, 6-wk nutritional trial was carried out with 154 outpatients (mean age 47.6 ± 12.6 y of age). The intervention group (n = 83) received a low-calorie diet plus 40 g/d of oat bran; the control group (n = 71) received a low-calorie diet only. MetS parameters and prevalence were calculated and compared (using two-tailed statistical tests) before and after follow-up. RESULTS After follow-up, a significant but similar reduction was observed in MetS prevalence (40% reduction, 63% and 64.8% prevalence in intervention and control groups, respectively; P = 0.226), body mass index, body weight, waist circumference, systolic and diastolic blood pressures, triacylglycerides, and blood glucose levels in both groups (P < 0.05). Mean high-density lipoprotein cholesterol (HDL-C) was reduced in the intervention group (43.6 ± 9.6 to 41.2 ± 9.5 mg/dL; P = 0.025), but not in the control group (44.6 ± 10.5 to 44.5 ± 12.1 mg/dL; P = 0.890). There was no significant difference in any of the variables between the groups, although the P-value for HDL-C was almost significant (P = 0.078). Calorie and dietetic fiber intake during the 6-wk period were similar in both groups. CONCLUSIONS Daily consumption of oat bran did not potentialize the beneficial effects of a traditional low-calorie diet on the prevalence of MetS and associated disorders. Additionally, it reduced HDL-C.
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Improvement of Lipoprotein Profile and Metabolic Endotoxemia by a Lifestyle Intervention That Modifies the Gut Microbiota in Subjects With Metabolic Syndrome.
Guevara-Cruz, M, Flores-López, AG, Aguilar-López, M, Sánchez-Tapia, M, Medina-Vera, I, Díaz, D, Tovar, AR, Torres, N
Journal of the American Heart Association. 2019;(17):e012401
Abstract
Background Metabolic syndrome (MetS) is a serious health problem over the world; thus, the aim of the present work was to develop a lifestyle intervention to decrease the dysbiosis of gut microbiota and reduce the biochemical abnormalities of MetS. Methods and Results The prevalence of MetS was evaluated in 1065 subjects of Mexico City, Mexico, and the gut microbiota in a subsample. Subjects with MetS were selected for a pragmatic study based on a lifestyle intervention with a low-saturated-fat diet, reduced-energy intake, with functional foods and physical activity, and a second group was selected for a randomized control-placebo study to assess the gut microbiota after the dietary intervention. Prevalence of MetS was 53%, and the higher the body mass index, the higher the gut microbiota dysbiosis. The higher the Homeostatic Model Assessment for Insulin Resistance, the lower the high-density lipoprotein cholesterol concentration. The pragmatic study revealed that after 15 days on a low-saturated-fat diet, there was a 24% reduction in serum triglycerides; and after a 75-day lifestyle intervention, MetS was reduced by 44.8%, with a reduction in low-density lipoprotein cholesterol, small low-density lipoprotein particles, glucose intolerance, lipopolysaccharide, and branched-chain amino acid. The randomized control-placebo study showed that after the lifestyle intervention, there was a decrease in the dysbiosis of the gut microbiota associated with a reduction in the Prevotella/ Bacteroides ratio and an increase in the abundance of Akkermansia muciniphila and Faecalibacterium prausnitzii. Conclusions A lifestyle intervention significantly decreased MetS components, small low-density lipoprotein particle concentration, gut microbiota dysbiosis, and metabolic endotoxemia, reducing the risk of atherosclerosis. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT03611140.
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Treatment choices for the glycaemic management of patients with type 2 diabetes and chronic kidney disease: Analysis of the SAIL patient linked dataset.
Min, T, Davies, GI, Rice, S, Chess, J, Stephens, JW
Diabetes & metabolic syndrome. 2018;(2):123-127
Abstract
AIMS: Chronic kidney disease (CKD) is common in type 2 diabetes and limits the treatment choices for glycaemic control. Our aim was to examine real-world prescribing for managing hyperglycaemia in the presence of CKD. METHODS The SAIL (Secure Anonymised Information Linkage) databank was used to examine prescribing during the period from the 1st of January to 30th December 2014. CKD was defined as:- none or mild CKD, eGFR ≥60mL/min/1.73m2; moderate CKD eGFR <60mL/min/1.73m2; and severe CKD eGFR <30mL/min/1.73m2 or requiring dialysis. RESULTS We identified 9585 subjects who received any form of glucose lowering therapy (8363 had no/mild CKD; 1137 moderate CKD; 85 severe CKD). There was a linear association between insulin use and CKD severity with approximately 54% of those with severe CKD receiving insulin. Sulphonylureas use did not differ among the CKD groups and was approximately 40%. Metformin showed a linear decrease across the groups, however approximately 21% in the severe CKD group received metformin. The use of dipeptidyl peptidase 4 inhibitors (DPP-4i) was approximately 20% and did not differ among groups. The DPP-4 inhibitor choice was:- 1% vildagliptin, 9% saxagliptin, 58% sitagliptin, and 32% linaglitpin. With respect to sitagliptin and saxagliptin, 72% and 62% received an inappropriately high dose in the setting of CKD. CONCLUSIONS We observed that a considerable proportion of patients with type 2 diabetes and CKD were receiving metformin and non dose-adjusted DPP-4 inhibitors. Careful consideration of medication use and dosaging is required in the setting of CKD and type 2 diabetes.
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Development of Metabolic Syndrome in Drug-Naive Adolescents After 12 Months of Second-Generation Antipsychotic Treatment.
Sjo, CP, Stenstrøm, AD, Bojesen, AB, Frølich, JS, Bilenberg, N
Journal of child and adolescent psychopharmacology. 2017;(10):884-891
Abstract
OBJECTIVES Mental illness is often accompanied by poor physical health and shorter life expectancy. Second-generation antipsychotics (SGAs) are suspected of increasing cardiovascular risk, possibly through development of metabolic syndrome (MetS), and the risk of adverse outcome is even higher if obesity or metabolic aberration starts in childhood or adolescence. METHODS Drug-naive adolescents were recruited after contact with an outpatient Psychosis Team. Changes relative to baseline in body mass index (BMI), waist circumference (WC), blood pressure (BP), fasting blood glucose (FBG), triglycerides (TG), and high-density lipoprotein (HDL) cholesterol were determined through regular follow-ups. RESULTS The sample included 35 SGA-naive patients aged 7-19 (mean: 15.5) with a diagnosis of psychosis. Over 12 months, the overall rate of MetS changed significantly (from 0% to 20% [p < 0.016]). There was a significant increase in BMI (18.4% [p < 0.001]), WC (14.3% [p < 0.001]), TG (25.2% [p = 0.039]), and FBG (3.6% [p = 0.038]), whereas there was a significant decrease in HDL (-11.5% [p < 0.001]). No significant change was found for BP. Compared with the 2014 Danish references BMI-for-age charts, after 12 months the participants' BMI had increased from 0.5 to 1.57 standard deviation (SD) above the 50th percentile for age and gender (p = 0.0001). CONCLUSION To our knowledge, this is the first study to include all the aspects of MetS in a sample of drug-naive adolescents followed over the first 12 months after starting SGA treatment. A significant shift in all parameters (except BP) toward MetS was found, presumably due to SGA use. Therefore, these adolescents will need proper follow-up, consisting of not only monitoring but also preventive measures to diminish these effects of SGA use.
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Evaluation of a culturally-adapted lifestyle intervention to treat elevated cardiometabolic risk of Latino adults in primary care (Vida Sana): A randomized controlled trial.
Rosas, LG, Lv, N, Xiao, L, Lewis, MA, Zavella, P, Kramer, MK, Luna, V, Ma, J
Contemporary clinical trials. 2016;:30-40
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Abstract
UNLABELLED Latinos bear a disproportionate burden of the dual pandemic of obesity and diabetes. However, successful interventions addressing this disparity through primary care are lacking. To address this gap, the 5-year Vida Sana (Healthy Life) study tests a culturally adapted and technology-enhanced group-based Diabetes Prevention Program intervention in a randomized controlled trial with overweight/obese Latino adults who have metabolic syndrome and/or pre-diabetes. Eligible, consenting patients (n=186) from a large community-based multispecialty group practice in Northern California will be randomly assigned to receive the culturally-adapted intervention or usual care. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework guided the planned evaluations. The primary aim is to determine the effectiveness of the intervention (the "E" in RE-AIM). We hypothesize that the intervention will lead to a greater mean reduction in weight at 24months (primary endpoint) vs. usual care. Secondary outcomes will include measures of cardiometabolic risk factors (e.g., blood pressure), psychosocial well-being (e.g., health-related quality of life), and behavior change (e.g., physical activity). The secondary aim is to evaluate the other RE-AIM dimensions using mixed methods: reach (e.g., participation rate of the target population), adoption (e.g., participating clinic and provider characteristics), implementation (e.g., intervention fidelity), and maintenance (e.g., sustainability in the practice setting). These findings have real word applicability with value to clinicians, patients, and other decision makers considering effective diabetes prevention programs for primary care that would support the millions of Latino adults who experience a disproportionate burden of diabetes. TRIAL REGISTRATION NCT02459691.