Strategic Lifestyle Intervention for Metabolic Syndrome (SLIM-MET)

Официальное название

Effects of Intensive Lifestyle Interventions (ILI) on Weight Loss and Cardiometabolic Risks in Obese Adults With Metabolic Syndrome: A Randomized Clinical Trial

Обзор

This study is a randomized, parallel-group, observer-masked clinical trial. A total of 200 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks. Furthermore, enhanced daily physical activities with walking more than 10,000 steps will be implemented. The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day. ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control. The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device (Fitbit Inspire 2). Participants are asked to attach the pedometer on their waist belt, except while bathing and sleeping. The ULI group will be instructed to follow habitual meal timing. In addition, all participants of both groups will receive the health education. Anthropometric, sociodemographic data, biochemical variables, and metabolic variables will be measured at baseline and during follow-up visit. DEXA and MRI of abdomen will be measured at baseline and during following up visits. The proposed trial is designed to provide 85% statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction \> 5% body weight over 24 weeks. After completion of the initial 24-week lifestyle intervention, which often has limited weight loss efficacy when used alone, a second-phase intervention will be conducted from week 26 to week 52. Participants in both the ILI and ULI groups will be randomly assigned in a 1:1 ratio to receive one of two evidence-based oral weight control medications: a GLP-1 receptor agonist (Rybelsus) or an SGLT-2 inhibitor (Forxiga), for a duration of 26 weeks. The ILI group will continue with the daily 8-hour time-restricted eating and 16-hour fasting regimen, along with walking more than 10,000 steps per day. This phase aims to evaluate the effects of these two medications on weight reduction and liver fat content, with or without prior 26-week intensive lifestyle intervention. After the 26-week medication intervention, all participants will be followed for an additional 52 weeks to assess the sustainability of weight loss.

Вмешательства

• Другое Strategic lifestyle and drug interventions
  Participants in the Intensive Lifestyle Intervention (ILI) group will follow a program including: 1. time-restricted eating with a 16:8 pattern (eating within an 8-hour window, fasting for 16 hours), 2. walking over 10,000 steps daily, and 3. a daily calorie reduction of 500 kcal (with macronutrient distribution: 40-55% carbohydrates, 15-20% protein, 20-30% fat). Participants in the Usual Lifestyle Intervention (ULI) group will maintain their habitual meal timing. After the initial 24-week li
• Другое Control
  Participants in the ULI group will maintain their usual lifestyle without intervention during the first 24 weeks. After the initial 24-week usual lifestyle intervention, participants in the ULI group will be randomly assigned in a 1:1 ratio to receive either Rybelsus (GLP-1 receptor agonist) or Forxiga (SGLT-2 inhibitor) for a duration of 26 weeks. This phase aims to assess the effects of these medications on weight reduction and liver fat content without prior intensive lifestyle intervention.

Первичные конечные точки

• Change in the metabolic syndrome severity score (Z score) after reduction > 5% body weight from baseline to 24 weeks [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• Men or women aged from ≥ 20 years to 65 years
• BMI 27.0 to 45.0 kg/m2 with metabolic syndrome by IDF definition

Критерии исключения

• History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis
• Diagnosis of type 1 or type 2 diabetes and regular taking oral or injection hypoglycemic therapy
• History of malignant tumors with active managements.
• History of medullary thyroid carcinoma or diagnosis of multiple endocrine neoplasia syndrome type 2 (MEN 2)
• Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2)
• History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months History of severe gastrointestinal diseases or gastrointestinal surgery in the past 6 months
• History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity without regular managements.
• History of hypersensitivity to semaglutide or any component of RYBELSUS®, or history of severe hypersensitivity reactions to Forxiga, such as anaphylaxis or angioedema.
• Taking medications affecting weight or energy intake/energy expenditure in the last 3 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician
• Currently participating in weight loss programs or weight change in the past 3 months (>5% current body weight)
• Women who are pregnant or plan to become pregnant
• Patients who cannot be followed for 3 years (due to a health situation or migration)
• Patients who are unwilling or unable to give informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Тайвань · 1 центр

• Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes — Zhunan

Публикации

• Isomaa B, Almgren P, Tuomi T, Forsen B, Lahti K, Nissen M, Taskinen MR, Groop L. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care. 2001 Apr;24(4):683-9. doi: 10.2337/diacare.24.4.683. PMID 11315831
• Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488. PMID 17167477
• Mottillo S, Filion KB, Genest J, Joseph L, Pilote L, Poirier P, Rinfret S, Schiffrin EL, Eisenberg MJ. The metabolic syndrome and cardiovascular risk a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Sep 28;56(14):1113-32. doi: 10.1016/j.jacc.2010.05.034. PMID 20863953
• Hanley AJ, Karter AJ, Williams K, Festa A, D'Agostino RB Jr, Wagenknecht LE, Haffner SM. Prediction of type 2 diabetes mellitus with alternative definitions of the metabolic syndrome: the Insulin Resistance Atherosclerosis Study. Circulation. 2005 Dec 13;112(24):3713-21. doi: 10.1161/CIRCULATIONAHA.105.559633. PMID 16344402
• Hsu CN, Hou CY, Hsu WH, Tain YL. Early-Life Origins of Metabolic Syndrome: Mechanisms and Preventive Aspects. Int J Mol Sci. 2021 Nov 2;22(21):11872. doi: 10.3390/ijms222111872. PMID 34769303
• Schulz LO, Bennett PH, Ravussin E, Kidd JR, Kidd KK, Esparza J, Valencia ME. Effects of traditional and western environments on prevalence of type 2 diabetes in Pima Indians in Mexico and the U.S. Diabetes Care. 2006 Aug;29(8):1866-71. doi: 10.2337/dc06-0138. PMID 16873794
• Gami AS, Witt BJ, Howard DE, Erwin PJ, Gami LA, Somers VK, Montori VM. Metabolic syndrome and risk of incident cardiovascular events and death: a systematic review and meta-analysis of longitudinal studies. J Am Coll Cardiol. 2007 Jan 30;49(4):403-14. doi: 10.1016/j.jacc.2006.09.032. Epub 2007 Jan 12. PMID 17258085
• Tsao YC, Li WC, Yeh WC, Ueng SW, Chiu SY, Chen JY. The Association between Metabolic Syndrome and Related Factors among the Community-Dwelling Indigenous Population in Taiwan. Int J Environ Res Public Health. 2020 Dec 2;17(23):8958. doi: 10.3390/ijerph17238958. PMID 33276457

Идентификаторы

NCT: NCT06271200 · MG-113-GP-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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