Study of Intensive Lifestyle and Medication Effects on Weight Loss and Heart Health in Obese Adults with Metabolic Syndrome

What this Trial Is About

This trial investigates the effects of intensive lifestyle interventions on weight loss and cardiometabolic risks in obese adults with metabolic syndrome. It enrolls 200 participants aged 20 to 65 years with metabolic syndrome and a body mass index BMI between 27.0 and 45.0 kgm2. The study aims to compare an intensive lifestyle intervention ILI involving time-restricted eating and increased physical activity with a usual lifestyle intervention ULI over 24 weeks, followed by medication treatment and long-term follow-up to assess sustained weight loss and metabolic improvements. Participants in the ILI group follow a daily 168 fasting pattern eating within 8 hours and fasting for 16 hours, walk more than 10,000 steps daily, and reduce their calorie intake by 500 kcals per day with specific macronutrient distribution. They use a mobile app and a wearable device Fitbit Inspire 2 to track diet and physical activity. The ULI group maintains their usual meal timing and lifestyle. After 24 weeks, both groups are randomly assigned to receive either a GLP-1 receptor agonist Rybelsus or an SGLT-2 inhibitor Forxiga for 26 weeks, with the ILI group continuing their lifestyle regimen. Following medication, all participants are monitored for an additional 52 weeks to evaluate long-term weight maintenance. During the study, researchers collect data on body measurements, biochemical and metabolic variables, and imaging studies including DEXA and abdominal MRI at baseline and follow-ups. Step counts are objectively measured in the ILI group using wearable devices. The primary outcome is the change in metabolic syndrome severity score after achieving more than 5% weight loss at 24 weeks. The study also assesses weight reduction and liver fat content during medication intervention and tracks the sustainability of weight loss over a total of 2.5 years of participation.

Strategic Lifestyle Intervention for Metabolic Syndrome (SLIM-MET)