LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDasman Diabetes Institute
About this trial
The aim of the current study is to determine whether resistance exercise and/or protein intake can preserve lean mass and improve physical function in patients with obesity initiating semaglutide/tirzepatide therapy. To achieve this aim the study will have the following objectives.
In people with obesity initiating semaglutide/tirzepatide therapy
1. Form a PPI group to refine the study protocol and establish study materials, 2. Quantify the effects of a pragmatic resistance exercise intervention and/or increasing protein intake on lean mass and physical function during semaglutide/tirzepatide induced weight loss, 3. Establish whether the resistance exercise intervention and/or increasing protein intake has concomitant benefits on glycaemic control, lipids, liver function, quality of life, physical activity and sleep during semaglutide/tirzepatide induced weight loss.
The participants will:
Begin their weight loss medication, starting at a low dose and then increasing the dose to maximize weight loss. They will be randomly assigned by a computer to ONE of the following groups and will be followed up to 6-months:
* Control group * Protein intake group * Muscle strengthening exercise group * Muscle strengthening exercise AND protein intake group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >/= 18 years
BMI >/= 27 kg/m2
Disqualifiers
Currently or in the past 6 months participating in any vigorous aerobic activity (>1h per week) or any resistance exercise.
BP of 160/100mmHg or higher
Any known medical condition that prevents participants from exercising safely
A personal or family history of medullary thyroid carcinoma
Trial design
Design model
Parallel
Treatments tested in this trial
Resistance exercise
BehavioralParticipants assigned to the resistance exercise group will be asked to perform exercises 3 times a week for the intervention period. The first 3 sessions of the exercise will be performed under the supervision of a qualified exercise specialist to ensure that the participants are happy with the exercises and are performing them appropriately. These will also be group sessions to encourage participants to build social connections to support them during the intervention. A similar group social session will take place at week 4 and then every 4 weeks of the study to overcome any issues with the exercises and to ensure progression to an appropriate intensity.
Protein Intake
Dietary supplementThe aim of this arm of the intervention is to ensure a protein intake of 1.6g/kg/day, as this was the intake level identified as the level after which no further effect was found on muscle mass in the meta-regression from (Morton et al., 2018). For the initial 2 weeks of the study, investigators will ask participants to consume 2 protein drinks, containing 25g protein (3g leucine), per day - one in the morning and one in the evening. At this stage, investigators won't know the magnitude of reduction of protein intake following initiation of semaglutide/tirzepatide treatment. After 2 weeks, when the first assessment of dietary intake after beginning semaglutide/tirzepatide treatment occurs, the additional protein will be based on the amount required to ensure 1.6g/kg/day with an aim to spread protein evenly across the day and aim for at least 25g protein (3g leucine) per meal or snack.
Treatment groups
232 Participants
are divided into 4 treatment groupsGroup A: Resistance exerciseExperimental treatment 1 intervention
Group B: Protein IntakeExperimental treatment 1 intervention
Group C: Resistance exercise + protein intakeExperimental treatment 2 interventions
Group D: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
MRI measured quadriceps cross sectional area (CSA)
At the mid-point of the thigh, investigators will measure the cross-sectional area of the quadriceps muscle and quantify muscle's thickness and size.
Time frame
From enrollment (at baseline) to the end of treatment at 6 months.Secondary outcomes
1
MRI measured intramuscular fat content (total thigh)
investigators will quantify intramuscular fat content
Time frame
From enrollment (at baseline) to the end of treatment at 6 months.2
MRI measured liver fat
investigators will also assess liver fat using 3-D sequence (MR-Touch) magnetic resonance elastography (MRE
Time frame
From enrollment (at baseline) to the end of treatment at 6 months.3
MRI measured liver stiffness
investigators will also assess liver stiffness using an IDEAL scan.
Time frame
From enrollment (at baseline) to the end of treatment at 6 months.4
Body Composition via DEXA scan
fat and fat free mass via Dual Energy X-ray Absorptiometry (DEXA)
Time frame
From enrollment (at baseline) to the end of treatment at 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dasman Diabetes Institute
Lead sponsor
University of Glasgow
Collaborator
Source ClinicalTrials.gov