200
Participants
Start Date
March 14, 2024
Primary Completion Date
January 19, 2026
Study Completion Date
December 31, 2027
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."
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."
RECRUITING
Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes, Zhunan
Tri-Service General Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
National Taiwan University Hospital Hsin-Chu Branch
OTHER
Taichung Armed Forces General Hospital
OTHER_GOV
National Health Research Institutes, Taiwan
OTHER