Clinical trial

Function and Lean Mass Preservation With Resistance Exercise During a GLP-1RA Treatment

Recruiting now · Not applicable · 1 countries · Registry ID NCT07457437

Recruiting nowNot applicableInterventional

What this study is about

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.

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

Age25 Years to 50 Years

SexFemale

Healthy volunteersAccepted

ConditionMuscle Mass and Strength, Obesity & Overweight, Physical Function

Full registry 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

Treatments and study arms

Progressive Resistance Exercise Training Program

Other

Participants in the GLP-1 + Exc group will participate in a 20 Week Progressive Resistance Exercise Training Program. This will be a low impact training program created by PVolve LLC. The plan will increase in session frequency and volume reaching 4 sessions per week at week 4 up until week 20 and will comprise of mostly banded, weighted or bodyweight exercises with small high intensity interval sessions after some of the sessions. Participants will attend the exercise classes on site at the St Luke's campus which will be delivered by PVolve instructors via video demonstration. Classes will be supervised by a member of the research team at all times.

Habitual physical activity guidelines

Other

Control group consisting of continuing habitual physical activity guidelines for 20 weeks

Primary outcomes

Skeletal Muscle MassSkeletal muscle mass will be plotted over time and we will compare the pre , mid and post values (weeks 0, 10 and 20) to see if there was a change in both groups.

Muscle Mass via (D3-Creatine). Skeletal muscle mass will be measured by the stable isotope labelled tracer creatine technique using methyl-\[D3\]-creatine (D3-Cr) to quantify whole-body skeletal muscle mass. A fasted urine sample will be collected after which a 30mg of D3-Cr will be administered at hr 0s. Total 24 hr urine volume output will be collected by the participant and returned to laboratory for analysis. Single urine samples will also be collected at 48 and 72 hrs after D3-Cr ingestion.

Muscle Thickness (Ultrasound)Muscle thickness in millimetres will be plotted over time (week 0, 4, 8, 10, 12, 16, 20) and compared between the two groups. Muscle thickness will also be measure at two separate time points during a follow up study at week 40 and 72 weeks from week 0.

Vastus lateralis and Bicep Brachi muscle thickness will be measured in the longitudinal and crosssectional plane via a 7.7-Hz linear transducer, using B-mode ultrasonography (Vscan Air; GE Healthcare, Chalfont St Giles, UK). Three images will be acquired at each site and analyzed using ImageJ v1.53t (National Institutes of Health, Bethesda, MD) software after being scaled from pixels to cm.

Study locations

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Nutritional Physiology Research Unit🇬🇧 Exeter, Devon, United Kingdom

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Professor Francis StephensContact

Email · Call 01392 6612157

Professor Benjamin WallContact

Email · Call 01392 72 4774

Professor Francis StephensPrincipal Investigator