Lifestyle changes for managing metabolic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.