Preserving Muscle Mass During Incretin-Induced Weight Loss
ConditionObesity (BMI > 35)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorKarolinska Institutet
About this trial
Treatment with appetite suppressant drugs, including incretin-based receptor agonists, generally leads to clinically meaningful weight loss and reduced cardiometabolic risk. However, weight loss may include not only loss of adipose tissue but also loss of skeletal muscle mass, which ultimately may impair physical function and metabolic health.
Resistance training is an effective strategy to maintain or increase skeletal muscle mass during weight loss, but its effects during treatment with appetite suppressant obesity medications have been studied insufficiently. This study will investigate whether unilateral resistance training during incretin-based receptor agonist treatment can preserve or improve skeletal muscle mass. Additionally, the study will determine whether preservation of muscle is accompanied by the preservation of muscle function and/or molecular adaptations in skeletal muscle, adipose tissue and blood.
Participants will be adults with obesity who are about to start treatment with an incretin-based receptor agonist as part of routine clinical care. During the 13-week intervention, participants will perform supervised unilateral resistance training two times per week, training one leg while the other leg serves as an internal control. Data and tissue collection will take place before treatment start and after 13 weeks. Assessments include whole-body magnetic resonance imaging, blood sampling, skeletal muscle and adipose tissue biopsies, physical function tests, questionnaires, and monitoring of physical activity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-64 years with obesity.
Planned initiation of incretin-based obesity pharmacotherapy as part of routine clinical care.
Able to participate in supervised unilateral resistance training.
Able to complete physical function tests.
Disqualifiers
Contraindication to magnetic resonance imaging.
Medical condition preventing resistance training or physical function testing.
Medical condition preventing skeletal muscle or adipose tissue biopsy.
Inability to understand study information in Swedish or provide informed consent.
Trial design
Design model
Single group
Treatments tested in this trial
Unilateral Resistance Training
BehavioralSupervised resistance training of one leg, two sessions per week for 13 weeks, during incretin-based receptor agonist treatment. The trained leg will be randomly assigned, and the contralateral leg will serve as an internal within-participant control.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Incretin treatment combined with unilateral resistance trainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Anterior Thigh Skeletal Muscle Volume
Change in skeletal muscle volume (L) of the anterior thigh muscles, measured by magnetic resonance imaging from baseline to 13 weeks. The primary comparison will be the difference in change from baseline to 13 weeks between the trained leg and the untrained contralateral leg.
Time frame
From baseline to 13 weeksSecondary outcomes
1
Change in knee extension strength
Change in lower-limb muscle strength measured using isokinetic (Nm) and isometric (Nm) knee extension tests.
Time frame
From baseline to 13 weeks2
Change in muscle fatigue tolerance
Change in peak torque (Nm) during repeated maximal concentric isokinetic contractions at 180°/s, assessed over 30 repetitions. Initial peak torque will be defined as the highest peak torque recorded during the first three repetitions, and final peak torque will be defined as the mean peak torque recorded during the last five repetitions. The decline in torque-generating capacity will be calculated as the absolute and relative decrease from initial to final peak torque.
Time frame
From baseline to 13 weeks3
Change in whole-body skeletal muscle mass
Change in whole-body skeletal muscle volume (L) measured by magnetic resonance imaging.
Time frame
From baseline to 13 weeks4
Change in total body fat volume
Change in total body fat volume (L) measured by magnetic resonance imaging.
Time frame
From baseline to 13 weeksOther outcomes
1
Change in body mass
Change in body mass during the intervention (kg).
Time frame
From baseline to 13 weeks2
Change in blood pressure
Change in resting systolic and diastolic blood pressure (mmHg).
Time frame
From baseline to 13 weeks3
Change in skeletal muscle molecular profile
Changes in molecular markers in skeletal muscle, including global (transcriptomics, proteomics, phosphoproteomics and metabolomics) and targeted gene expression, protein abundance, and specific molecular pathways.
Time frame
From baseline to 13 weeks4
Change in adipose tissue molecular profile
Changes in molecular markers in subcutaneous adipose tissue, including gene expression (transcriptomics), proteins (proteomics, phosphoproteomics \& metabolomics), inflammatory markers, and specific molecular pathways.
Time frame
From baseline to 13 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
Source ClinicalTrials.gov
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