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Not yet recruiting 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

No phase Interventional Obesity Sarcopenia Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resistance exercise, Lifestyle recommendations.
Who it may be relevant to
Registry conditions: Obesity, Sarcopenia, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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: a Randomized Controlled Trial Protocol

Overview

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.

Detailed description

Pharmacologically induced weight loss with glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists such as tirzepatide is associated with significant reductions in lean body mass, raising concerns regarding muscle function and long-term outcomes. Resistance exercise is the most effective intervention to preserve muscle mass during weight loss; however, evidence combining these approaches is limited.

This study is a prospective, two-center, single-blinded, randomized controlled trial designed to evaluate whether structured resistance exercise enhances muscle preservation and functional outcomes in individuals receiving tirzepatide therapy.

Interventions

  • Other Resistance exercise
    A 24-week home-based resistance exercises using elastic band and bodyweight
  • Other Lifestyle recommendations
    Lifestyle recommendations including physical activity and nutritional advice

Primary outcome measures

  • Change in muscle thickness [Time frame: Baseline, 12 weeks, 24 weeks]
  • Muscle echo intensity [Time frame: Baseline, 12 weeks, 24 weeks]
Secondary outcome measures (12)
  • Muscle strength (handheld dynamometer) [Time frame: Baseline, 12 weeks, 24 weeks]
  • Body weight [Time frame: Baseline, 12 weeks, 24 weeks]
  • Six-minute walk test [Time frame: Baseline, 12 weeks, 24 weeks]
  • Physical activity [Time frame: Baseline, 12 weeks, 24 weeks]
  • Nutritional status (3-day food record) [Time frame: Baseline, 12 weeks, 24 weeks]
  • Quality of life (Short Form-36) [Time frame: Baseline, 12 weeks, 24 weeks]
  • Clinical parameters (blood pressure) [Time frame: Baseline, 12 weeks, 24 weeks]
  • Height [Time frame: Baseline, 12 weeks, 24 weeks]
  • Body mass index [Time frame: Baseline, 12 weeks, 24 weeks]
  • Body fat percentage [Time frame: Baseline, 12 weeks, 24 weeks]
  • Fat free mass [Time frame: Baseline, 12 weeks, 24 weeks]
  • Chair stand test [Time frame: Baseline, 12 weeks, 24 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07609160 · Özgül Öztürk · Grant proposal submitted

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗