GLP-1 Receptor Agonist Use and Sarcopenia in Obese Individuals Without Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul Saglik Bilimleri University
About this trial
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dual GLP-1/GIP agonists such as semaglutide and tirzepatide produce marked weight loss in people with obesity, with reported reductions of about 15-20%. Rapid weight loss may reduce not only fat mass but also lean body mass and skeletal muscle mass, raising concern about sarcopenia and sarcopenic obesity. Evidence in non-diabetic obese individuals is limited and inconsistent. This prospective descriptive study will assess muscle mass, muscle strength, physical performance and sarcopenia risk in non-diabetic obese adults starting GLP-1 RA therapy, at baseline and at month 3, and will examine how weight loss relates to changes in body composition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Diagnosis of obesity (BMI >30 kg/m²)
Currently using a GLP-1 RA
No hearing, speech or cognitive impairment
Disqualifiers
Diagnosis of diabetes
History of chronic kidney failure, chronic liver disease, decompensated heart failure or malignancy
Pregnancy or breastfeeding
Walking impairment
Trial population
Adults with obesity and no diabetes referred from the Endocrinology and Metabolism and Internal Medicine outpatient clinics to the Diabetes Education Unit and using a GLP-1 RA.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
GLP-1 receptor agonist (e.g., semaglutide, tirzepatide) - prescribed by the treating physician as standard care; the study does not assign or alter treatment.
DrugGLP-1 receptor agonist (GLP-1 RA) or dual GLP-1/GIP receptor agonist (e.g., semaglutide, tirzepatide) prescribed by the treating physician as routine clinical care for obesity in adults without diabetes. The agent, dose and duration are determined by the treating physician; the study does not assign, supply or modify treatment. Participants are enrolled at GLP-1 RA initiation and followed for 3 months at the Diabetes Education Unit. Study-specific assessments at baseline and month 3: SARC-F questionnaire, handgrip strength (hydraulic dynamometer), five-times chair stand test and 4-metre gait speed. Body composition by bioelectrical impedance analysis (skeletal muscle mass index, fat mass) and routine laboratory results are taken from standard clinical follow-up; no additional blood tests are requested.
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Non-diabetic obese adults receiving a GLP-1 RA (or GLP-1/GIP dual agonist) for obesity1 intervention
Trial outcomes
Primary outcomes
1
Change in SARC-F (Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls) total score
SARC-F is a 5-item sarcopenia screening questionnaire. Total score ranges from 0 to 10, and higher scores indicate a worse outcome (greater risk of sarcopenia). Change = month 3 score minus baseline score, reported in points on the scale.
Time frame
Baseline (GLP-1 RA initiation) and 3 monthsSecondary outcomes
1
Number of participants with a positive SARC-F screening result
Positive screening is defined as a SARC-F total score of 4 or higher (scale range 0 to 10; higher scores indicate a worse outcome). Reported as number of participants.
Time frame
Baseline and 3 monthsOther outcomes
1
Change in handgrip strength
Maximum handgrip strength in kilograms, measured with a hydraulic hand dynamometer (seated, elbow at 90°, three trials per hand; highest of six values used). Change = month 3 minus baseline. Higher values indicate greater strength (better outcome).
Time frame
baseline and 3 months.Sponsors and contacts
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Source ClinicalTrials.gov