Exercise and Protein to Reduce Muscle Loss During GLP-1-Based Treatment in Type 2 Diabetes

A vizsgálat adatai

Ki végzi

German Diabetes Center

Azonosító

NCT07926152

A regiszteradat frissítve

2026. november 9.

Eredeti leírás

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:A teljes eredeti leírásKevesebb

Combined Exercise and Protein Supplementation to Preserve Skeletal Muscle During GLP-1 Receptor Agonist Treatment in People With Type 2 Diabetes: A Randomized Controlled Multicenter Trial

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

Bevonási feltételek: Signed and dated written informed consent prior to any study-specific procedures; Men and women aged 18 years or older; Body mass index (BMI) ≥27 kg/m² (upper limit determined by MRI bore size, approximately 42 kg/m²); Type 2 diabetes diagnosed according to American Diabetes Association (ADA) criteria; HbA1c <9%; Treatment with tirzepatide or semaglutide (target dose >1 mg/week) initiated by the treating physician as part of routine clinical care within 8 weeks prior to enrollment; Stable body weight (±5%) during the 3 months prior to initiation of GLP-1 receptor agonist therapy; Able to participate in exercise testing and supervised exercise training.

Kizáró feltételek: Insulin therapy (basal or bolus); Sulfonylurea therapy above a low dose (≤50% of the maximum approved daily dose, e.g. glimepiride ≤3 mg/day, gliclazide MR ≤60 mg/day, glibenclamide ≤5.25 mg/day); Use of other weight-loss medication, including other GLP-1 receptor agonists, within the last 3 months; Systemic (oral or intravenous) glucocorticoid therapy within the last 3 months; Immunomodulatory or biological therapy; Concurrent participation in another interventional clinical study; Type 1 diabetes or secondary forms of diabetes; Medication affecting body weight or metabolism, unless on a stable dose for ≥3 months with clinically stable disease (e.g. thyroid hormone replacement with euthyroidism); Heart failure or clinically significant cardiovascular disease precluding safe participation in an exercise program, as judged by the study physician; Myocardial infarction or stroke within the last 12 months; Uncontrolled hypertension; Severe pulmonary disease limiting exercise capacity (e.g. COPD GOLD III-IV, long-term oxygen therapy); Symptomatic peripheral arterial disease (Fontaine stage ≥II); ankle-brachial index is measured at screening in case of clinical suspicion; Significant liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD); History of acute or chronic pancreatitis; Uncontrolled thyroid disease; Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2); Diabetic neuropathy with significant functional impairment; Muscular disease (e.g. myopathy, muscular dystrophy); Contraindications to MRI according to local MRI safety standards (e.g. cardiac pacemaker, non-MR-conditional metallic implants, claustrophobia); MR-conditional implants (e.g. surgical clips, joint prostheses) are permitted after assessment by the responsible radiologist; Active malignancy or malignancy within the last 5 years (except adequately treated non-melanoma skin cancer); Autoimmune or systemic inflammatory disease requiring systemic immunosuppressive or glucocorticoid therapy, or affecting skeletal muscle or metabolism (e.g. rheumatoid arthritis, systemic lupus erythematosus, inflammatory myopathies, sarcoidosis); localized or low-risk conditions (e.g. Hashimoto's thyroiditis, vitiligo, psoriasis or lichen planus without systemic therapy) are permitted; HIV infection or active hepatitis B or C; Vegan diet or known cow's milk protein allergy (due to whey protein supplementation); Therapeutic anticoagulation or known bleeding or coagulation disorder; Known allergy to local anesthetics (e.g. lidocaine); Chronic kidney disease with eGFR <30 mL/min/1.73 m²; Diabetic retinopathy requiring treatment or at an advanced stage; Orthopedic or neurological limitations preventing exercise; Creatine kinase >3 times the upper limit of normal at screening (one repeat measurement after ≥72 hours without strenuous exercise is permitted); Body size exceeding MRI bore limits; Pregnancy or breastfeeding; Structured exercise training >2 hours/week at the time of enrollment; Alcohol or substance abuse; Blood donation within the last 3 months; Inability to comply with study procedures.

ClinicalTrials.gov NCT07926152