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Strategic Lifestyle Intervention for Metabolic Syndrome (SLIM-MET)

RecruitingNAAges 20 Years - 65 YearsAllNational Health Research Institutes, Taiwan
NCT06271200 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Men or women aged from ≥ 20 years to 65 years * BMI 27.0 to 45.0 kg/m2 with metabolic syndrome by IDF definition Exclusion Criteria: * 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
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What it tests

  • Strategic lifestyle and drug interventions
  • Control
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Where

1 site
Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes
Zhunan, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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