Strategic Lifestyle Intervention for Metabolic Syndrome (SLIM-MET)

April 7, 2026 updated by: Wayne Huey-Herng Sheu, National Health Research Institutes, Taiwan

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Miaoli County
      • Zhunan, Miaoli County, Taiwan, 350
        • Recruiting
        • Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive lifestyle intervention
Participants in the ILI group will receive an intensive lifestyle program including time-restricted eating and increased physical activity.
Other: 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 lifestyle program, ILI participants will be randomized (1:1) to receive either a GLP-1 receptor agonist (Rybelsus) or an SGLT-2 inhibitor (Forxiga) for 26 weeks, while continuing their lifestyle regimen. This phase will assess the impact of medication-with or without prior lifestyle intervention-on weight loss and liver fat. All participants will then be followed for an additional 52 weeks to evaluate long-term weight maintenance.
Other: Control
Participants in the ULI group will maintain their usual lifestyle without intervention during the first 24 weeks.
Other: 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. All participants will be followed for an additional 52 weeks to evaluate the long-term sustainability of weight loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the metabolic syndrome severity score (Z score) after reduction > 5% body weight from baseline to 24 weeks
Time Frame: 24 weeks
Metabolic syndrome severity will be measured by using Z score derived from Taiwan Biobank and Metabolic syndrome severity score (MSSS): MSSS calculation will be performed with the online tool "METS Severity Calculator" at ttp://publichealth.hsc.wvu.edu/biostatistics/metabolic-syndrome-severity-calculator/mets-severity-calculator/. The equations for calculation of MSSS are based on the NHANES study in the USA with the following arguments: age, race, gender, waist circumference, triglycerides (TG), high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, systolic blood pressure (SBP) and blood glucose levels.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Research Institutes, Taiwan

Collaborators

Chang Gung Memorial Hospital
Tri-Service General Hospital
National Taiwan University Hospital Hsin-Chu Branch
Taichung Armed Forces General Hospital

Investigators

  • Principal Investigator: Wayne Huey-Herng Sheu, MD, PhD, National Health Research Institutes, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

October 10, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG-113-GP-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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