Lifestyle changes for managing metabolic syndrome
Effects of Intensive Lifestyle Interventions (ILI) on Weight Loss and Cardiometabolic Risks in Obese Adults With Metabolic Syndrome: A Randomized Clinical Trial
This study is testing whether a new lifestyle program that includes intermittent fasting, exercise, and diet changes can help people with metabolic syndrome improve their health compared to those who stick to their usual habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | National Health Research Institutes, Taiwan Academic / other |
| Locations | 1 site (Zhunan, Miaoli County) |
| Trial ID | NCT06271200 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves a randomized, parallel-group design with 200 obese participants diagnosed with metabolic syndrome. Participants will be divided into two groups: one receiving a strategic lifestyle intervention that includes intermittent fasting, increased physical activity, and dietary modifications, while the other group will follow their usual lifestyle. The intervention group will utilize a mobile app to track their progress and wear a device to monitor their daily step count over a 24-week period. The goal is to assess the effectiveness of these lifestyle changes in improving metabolic health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 to 65 with a BMI between 27.0 and 45.0 who meet the criteria for metabolic syndrome.
Not a fit: Patients with a history of diabetes, serious cardiovascular diseases, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve weight management and metabolic health for patients with metabolic syndrome.
How similar studies have performed: Previous studies have shown positive outcomes with lifestyle interventions for metabolic syndrome, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zhunan, Miaoli County
- Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes — Zhunan, Miaoli County, Taiwan (Recruiting)
Study contacts
- Principal investigator: Wayne Huey-Herng Sheu, MD, PhD — National Health Research Institutes, Taiwan
- Study coordinator: Vivian Wang, Master
- Email: ywwang@nhri.edu.tw
- Phone: +886-37-206166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.