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NCT07609160
Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals
Conditions: Obesity, Sarcopenia, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 108
Sponsor: Acibadem University
Summary
This randomized controlled trial aims to investigate the effects of a 24-week home-based progressive resistance exercise program combined with tirzepatide treatment on skeletal muscle mass, muscle quality, and functional capacity in overweight and obese individuals. A total of 108 participants initiating tirzepatide therapy will be randomized to either exercise plus pharmacotherapy or pharmacotherapy alone. The primary outcome is change in thigh muscle thickness and echo intensity assessed by ultrasonography.
Eligibility Criteria
Inclusion Criteria:
* initiation of tirzepatide-based pharmacological treatment as prescribed by an endocrinology and metabolism specialist,
* body mass index (BMI) ≥27 kg/m² and the presence of a comorbidity condition or BMI≥30 kg/m²
* age between 18 and 65 years
Exclusion Criteria:
* diagnosis of type 1 or type 2 diabetes mellitus
* presence of cerebrovascular, hematological, pulmonary, rheumatological, or neurological disorders
* current participation in a structured diet or exercise program
* use of weight-loss medications within the past 12 months
* history of upper or lower extremity surgery or injury within the past 6 months
* any contraindication to resistance exercise as determined by the treating physician.
Source: ClinicalTrials.gov (NCT07609160). StuddyBuddy aggregates publicly available trial information.