NCT07457437 Function and Lean Mass Preservation With Resistance Exercise During a GLP-1RA Treatment
| NCT ID | NCT07457437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Exeter |
| Condition | Muscle Mass and Strength |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-12-01 |
Trial Parameters
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Brief Summary
This study aims to investigate the effect that a structured, progressive resistance exercise program may have on maintaining the muscle mass and physical function of overweight/ obese females whilst they experience a tirzepatide (GLP-1/GIP receptor agonist) induced weight loss. Overweight and obese females aged 25-50 will be recruited for the study, they will require a BMI of \>30 or \>27 with one obesity related comorbidity (excluding diabetes). They will be screened, prescribed tirzepatide and then randomly assigned to either the intervention (GLP-1/GIP + Exercise) or the control group (GLP-1/GIP). Groups will then be split into pre and peri menopausal groups to provide a further exploratory pathway looking analysing if the menopause transition may have any effect on our outcome variables. This was proposed as in the UK females are more likely to begin GLP-1RA treatment. Both groups will be given an industry standard treatment of tirzepatide over 20 weeks starting at a dose of 2.5mg/week and following the dose titration process of +2.5mg/week every four weeks outlined by its manufacturers. The Exercise Group (GLP-1 +EXC) will be given the same tirzepatide prescription alongside following a progressive resistance exercise program. The exercise program will follow a similar structure to previous work in which participants will complete a propriety 20-wk whole body, low impact resistance exercise training program four times a week. The exercise sessions will be up to an hour and will be instructor lead by video and supervised by a member of the research team at The University of Exeter.
Eligibility Criteria
Inclusion Criteria: * 25-50 years old * BMI ≥27 kg/m2 with one obesity related co-morbidity or a BMI between ≥30 and 35 kg/m2 * Female Exclusion Criteria: * Previous GLP-1RA use * Diabetes (Type 1 and 2) * Contraindicative health condition to GLP-1/GIP * Fail clinically administered health screening form for tirzepatide prescription * Pregnant or wanting to become pregnant in the next 6 months * Has or has previously had an eating disorder * Inability to perform exercise program and exercise tests * Advised not to exercise by their general practitioner or medical professional * Current or recent injury within the last 6 months that may affect the ability to carry out resistance exercise * Has consistently resistance trained previously (\>10 sessions per year) * Currently taking medication or supplements that have been shown to impact muscle function and muscle mass in the last 6 months * Current or recent, ≤6 months, smoker * Currently on HRT