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Life sciences · Interventional Study
ClinicalTrials.gov · November 9, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07926152). This is a study registration, not published results. Lead sponsor: German Diabetes Center. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 94 participants (ESTIMATED). Conditions: Type 2 Diabetes (T2DM), Obesity & Overweight, Sarcopenia. Interventions: BEHAVIORAL: Supervised exercise training; DIETARY_SUPPLEMENT: protein supplement; BEHAVIORAL: Standardized lifestyle counseling. Primary outcome measures: Change in Contractile Thigh Muscle Volume , Baseline to week 24. Brief summary: The goal of this clinical trial is to learn if supervised exercise training combined with a daily protein supplement can reduce the loss of muscle mass and muscle strength in adults with type 2 diabetes who have recently started treatment with semaglutide or tirzepatide. The main questions it aims to answer are: * Does the exercise and protein program reduce the loss of thigh muscle volume over 24 weeks? * Does the program improve muscle strength, physical fitness, insulin sensitivity and liver lipids? Researchers will compare participants who take part in the exercise and protein program to participants who receive usual care only, to see if the program helps to preserve skeletal muscle during treatment-related weight loss. All participants will: * Continue their semaglutide or tirzepatide treatment as prescribed by their own doctor * Receive one lifestyle counselling session on nutrition and physical activity at the start of the study * Attend two study visits, at the start and after 24 weeks, each lasting two days, including MRI scans, body composition measurement, blood tests, an insulin sensitivity test (clamp), small muscle and fat tissue samples, and tests of muscle strength and fitness * Collect their urine over 24 hours before each study visit * Keep a food diary and complete questionnaires at the start and after 6, 12, 18 and 24 weeks Participants in the exercise and protein group will also: * Take part in supervised exercise training (strength and interval training) three times per week for 24 weeks * Drink a protein shake (whey protein) every day