Health TrialsbyHealthPanel

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

ConditionsMuscle Mass and StrengthObesity & OverweightPhysical Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-50
SponsorUniversity of Exeter

About this trial

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

This trial accepts healthy volunteers

Qualifiers

25-50 years old

BMI ≥27 kg/m2 with one obesity related co-morbidity or a BMI between ≥30 and 35 kg/m2

Female

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Progressive Resistance Exercise Training Program

    Other intervention

    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 intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: GLP-1RA+EXERCISEExperimental treatment 1 intervention
Group B: GLP-1RAPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Skeletal Muscle Mass

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.

Time frame
Skeletal 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.
2

Muscle Thickness (Ultrasound)

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.

Time frame
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.

Secondary outcomes

1

Isokinetic dynamometry (Bicep and Quadriceps) Peak Torque (Nm/kg)

Knee extension and elbow flexion peak torque (PT) will be measured by an isokinetic dynamometer (Biodex Medical Systems, Shirley, NY). Participants will be positioned according to the Biodex manual (Biodex Medical Systems 3) at the familiarization visit and all subsequent visits. Before the test participants will warm up for 5 mins at 60-90rpm on a stationary bike (Watt Bike Atom; Wattbike Ltd, Nottingham, UK) and perform three repetitions on the dynamometer at 30, 60 and 90% effort. Participants will then perform 2 x 5 repetitions of maximal isokinetic contractions separated by 90s rest, the highest value will be taken as PT. Verbal encouragement will l be provided by the researcher during each test.

Time frame
Peak torque in Nm/kg will be compared between pre, mid and post (weeks 0, 10 and 20) in both groups and plotted against time. As well as during follow ups at weeks 40 and 72
2

Isokinetic Dynamometry (Quadriceps and Bicep) Fatigue Profile (%)

Knee extension and elbow flexion fatigue profile will then be measured on the isokinetic dynamometer (Biodex Medical Systems, Shirley, NY) after 3 minutes rest. Participants will perform 30 maximal-effort concentric repetitions on their dominant limbs.

Time frame
Fatigue profile (%) will be compared between pre, mid and post (weeks 0, 10 and 20) in both groups and plotted against time. As well as during follow ups at weeks 40 and 72
3

Physical Function 60 second sit-to-stand test

One minute Sit to Stand test (1MSTST) participants will be asked to stand up and sit down as many times as possible in 60 seconds on to a conventional chair without arm rests. The number of completed repetitions in 60 seconds will be recorded.

Time frame
Sit to stand scores will be compared between groups and pre, mid and post intervention (weeks 0, 10 and 20). The measured again at follow up visits in week 40 and 72.
4

Dynamic Balance, Y-balance Test

Dynamic balance will be measured using the Y-balance test (LQ-YBT). Participants will be asked to move a reach indicator block as far as possible in the anterior (ANT), posteromedial (PM), and posterolateral (PL) directions with their non standing foot from the central block of the YBT Kit TM (Fysio Supplies B.V). Participant hands will stay on hips and the heel will remain flat. Distances will be measured to the nearest half centimetre.

Time frame
Balance test scores will be compared between groups and at pre, mid and post intervention (weeks 0, 10 and 20). Then again at follow up visits at weeks 40 and 72.

Other outcomes

1

Quality of Life Short Form 36

Data on lifestyle quality will be assessed by using SF-36 questionnaire. It is comprised of 36 questions which are all numerically scored and weighted to provide scores for the following 8 categories related to quality of life. These are: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health. These categories are all given a score from 0-100 with 0 being the lowest score for quality of life and 100 being the highest.

Time frame
The SF-36 will be completed remotely on weeks 0, 10 and 20.
2

The Pittsburgh Sleep Quality Index (PSQI)

Data on sleep quality will be assessed by using Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index (PSQI) is scored by calculating seven component scores (0-3 each) based on 19 self-rated questions, which are then summed for a global score (0-21). A higher score indicates poorer sleep quality, with a total score \>5 indicating poor sleep. Components include sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, medication use, and daytime dysfunction

Time frame
The PSQI will be completed remotely on weeks 0, 10 and 20.
3

Habitual physical activity (MET)

Physical activity be measured by using a GENEActiv accelerometer for a 7-day period.

Time frame
Physical activity will be measured on week 0, 10 and 20.
4

Basal Metabolic Rate (BMR)

Basal metabolic rate will be calculated by using indirect calorimetry.

Time frame
Basal metabolic rate will be measured on week 0 and 20. Then during the follow up visits at week 40 and 72.

Sponsors and contacts

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University of Exeter

Lead sponsor

Source ClinicalTrials.gov
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