Clinical trial

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

Opening soon · Not applicable · 0 countries · Registry ID NCT07609160

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Sarcopenia, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities

Full registry 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.

Treatments and study arms

Resistance exercise

Other

A 24-week home-based resistance exercises using elastic band and bodyweight

Lifestyle recommendations

Other

Lifestyle recommendations including physical activity and nutritional advice

Primary outcomes

Change in muscle thicknessBaseline, 12 weeks, 24 weeks

Muscle thickness of the thigh (quadriceps femoris) will be assessed using a portable ultrasound and will be presented in millimeters (mm).

Muscle echo intensityBaseline, 12 weeks, 24 weeks

Echo intensity will be assessed via a portable muscle ultrasonography using grayscale analysis (0-255 scale) within a standardized region of interest using ImageJ software (National Institutes of Health, USA), with higher values indicating greater intramuscular fat and fibrous tissue infiltration and thus poorer muscle quality. Assessments will include quadriceps femoris.

Study locations

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No public site location was included in this record. Check the original registry for updates.