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

NCT07609160 | Not Yet Recruiting

• 2 other identifiers: Özgül ÖztürkGrant proposal submitted
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity; Sarcopenia; Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities

Keywords

exercise; physical activity; muscle; physical function

Outcome Measures

Primary Outcomes (2)

• Change in muscle thickness

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

  Baseline, 12 weeks, 24 weeks

• Muscle echo intensity

  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.

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (18)

• Muscle strength (handheld dynamometer)

  Baseline, 12 weeks, 24 weeks

• Body weight

  Baseline, 12 weeks, 24 weeks

• Six-minute walk test

  Baseline, 12 weeks, 24 weeks

• Physical activity

  Baseline, 12 weeks, 24 weeks

• Nutritional status (3-day food record)

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

Resistance Exercise + Tirzepatide

EXPERIMENTAL

24-week home-based progressive resistance exercise program (3 sessions/week) using elastic bands and bodyweight exercises, combined with tirzepatide treatment and general lifestyle recommendations..

Other: Resistance exercise; Other: Lifestyle recommendations

Tirzepatide Alone

ACTIVE COMPARATOR

Standard tirzepatide treatment with usual care and general lifestyle recommendations.

Other: Lifestyle recommendations

Interventions

Resistance exercise OTHER

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

Resistance Exercise + Tirzepatide

Lifestyle recommendations OTHER

Lifestyle recommendations including physical activity and nutritional advice

Resistance Exercise + Tirzepatide; Tirzepatide Alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acibadem University: lead

MeSH Terms

Conditions

Obesity; Sarcopenia; Overweight; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Özgül Öztürk, Associate Professor

CONTACT

902165004185; ozgul.ozturk@acibadem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor, Data Analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share