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← All trials/NCT07609160

Not yet recruitingPhase NA

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

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

Assets

GLP-1 / incretin class catch-all / Tirzepatide

Listed sites

0

Recruiting sites

-

Estimated enrollment

108

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥27

Primary endpoints

•Muscle thickness•Muscle echo intensity

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07609160
Org study IDÖzgül Öztürk
Secondary IDGrant proposal submittedAcıbadem University

Timeline

Milestones

Study first posted2026-05-27actual
Last update posted2026-05-27actual
Study start2026-11-01estimated
Primary completion2027-11-30estimated
Study completion2028-01-01estimated

Assets

Investigational agents

GLP-1 / incretin class catch-allTirzepatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
13
Weight & body composition
2
Cardiometabolic biomarkers
2
Glycemic / diabetes
1
Patient-reported / QoL
1
Other clinical outcomes
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Body weight

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint

Body mass index

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Clinical measures (fasting glucose)

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Clinical parameters (blood pressure)

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint

Clinical parameters (lipid profile)

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Quality of life (Short Form-36)

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Self-reported physical activity

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Other (unclassified)

13 endpoints
Primary/protocol endpoint/low confidence

Change in muscle thickness

Time frame:Baseline, 12 weeks, 24 weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

Muscle echo intensity

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Muscle strength (handheld dynamometer)

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Six-minute walk test

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Physical activity

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Nutritional status (3-day food record)

Time frame:Baseline, 12 weeks, 24 weeks

categorical status, descriptive

Secondary/protocol endpoint/low confidence

Height

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Body fat percentage

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Fat free mass

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Chair stand test

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Grip strength

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Muscle thickness

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Muscle echo intensity

Time frame:Baseline, 12 weeks, 24 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.