GLP-1 Receptor Agonist Use and Sarcopenia in Obese Individuals Without Diabetes

NCT07858864 — Recruiting, 42 participants, Istanbul Saglik Bilimleri University

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Evaluation of the Relationship Between GLP-1 Receptor Agonist Use and Sarcopenia in Non-Diabetic Obese Individuals: A Prospective Descriptive Study

RegistryNCT07858864, acronym GLP1-SARCO
StatusRecruiting
Study typeObservational
Enrollment42 (Estimated)
SponsorIstanbul Saglik Bilimleri University (Other)
ConditionsObesity, Sarcopenia
InterventionsGLP-1 receptor agonist (e.g., semaglutide, tirzepatide) - prescribed by the treating physician as standard care; the study does not assign or alter treatment. (Drug)
Datesstart 2026-05-30, primary completion 2026-11-30 (estimated), completion 2026-11-30 (estimated), first posted 2026-10-05, last updated 2026-10-08
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials for Sarcopenia All trials of GLP-1 receptor agonist (e.g., semaglutide, tirzepatide) - prescribed by the treating physician as standard care; the study does not assign or alter treatment.

-Summary

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.

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+Detailed description

Adults aged 18 years or older with obesity (BMI >30 kg/m²) and without diabetes, who are referred from the Endocrinology and Metabolism and Internal Medicine outpatient clinics to the Diabetes Education Unit and are receiving a GLP-1 RA for its approved indication, will be enrolled after verbal consent. Sarcopenia screening uses the SARC-F questionnaire (strength, assistance in walking, rise from a chair, climb stairs). Muscle strength and performance are assessed by handgrip strength (hydraulic hand dynamometer, seated, elbow at 90°, three trials per hand, highest value recorded, population-specific EWGSOP2 cut-offs), the five-times chair stand test (>15 seconds indicates high risk) and 4-metre gait speed (<0.8 m/s indicates low performance). Skeletal muscle mass index (SMMI), BMI and fat mass are obtained by bioelectrical impedance analysis (BIA), which is already performed at every routine follow-up visit. Routine laboratory results are transcribed from clinical records; no additional blood samples are requested. Assessments occur at GLP-1 RA initiation and at month 3.

+Arms and interventions

ArmTypeInterventionsDescription
Non-diabetic obese adults receiving a GLP-1 RA (or GLP-1/GIP dual agonist) for obesityDrug: GLP-1 receptor agonist (e.g., semaglutide, tirzepatide) - prescribed by the treating physician as standard care; the study does not assign or alter treatment.Adults (≥18 years) with BMI ≥30 kg/m² and no diabetes who start GLP-1 RA treatment under routine clinical care and are followed at the Diabetes Education Unit.
  • GLP-1 receptor agonist (e.g., semaglutide, tirzepatide) - prescribed by the treating physician as standard care; the study does not assign or alter treatment. (Drug): GLP-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.

+Outcome measures

Primary outcomes

  • Change in SARC-F (Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls) total score [Baseline (GLP-1 RA initiation) and 3 months]: 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.

Secondary outcomes

  • Number of participants with a positive SARC-F screening result [Baseline and 3 months]: 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.

Other outcomes

  • Change in handgrip strength [baseline and 3 months.]: 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).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age 18 years or older
* Diagnosis of obesity (BMI >30 kg/m²)
* Currently using a GLP-1 RA
* No hearing, speech or cognitive impairment
* Not receiving treatment for major depressive disorder and not using antidepressants
* Verbal consent to participate

Exclusion Criteria:

* Diagnosis of diabetes
* History of chronic kidney failure, chronic liver disease, decompensated heart failure or malignancy
* Pregnancy or breastfeeding
* Walking impairment
* Not meeting inclusion criteria or unwilling to participate

+Locations (1)

FacilityCityCountryStatus
Kanuni Sultan Süleyman Training and Research HospitalIstanbul, KucukcekmeceTurkey (Türkiye)Recruiting

+Publications

  • Aroda VR, Erhan U, Jelnes P, Meier JJ, Abildlund MT, Pratley R, Vilsboll T, Husain M. Safety and tolerability of semaglutide across the SUSTAIN and PIONEER phase IIIa clinical trial programmes. Diabetes Obes Metab. 2023 May;25(5):1385-1397. doi: 10.1111/dom.14990. Epub 2023 Feb 21. PMID 36700417
  • Sargeant JA, Henson J, King JA, Yates T, Khunti K, Davies MJ. A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors on Lean Body Mass in Humans. Endocrinol Metab (Seoul). 2019 Sep;34(3):247-262. doi: 10.3803/EnM.2019.34.3.247. PMID 31565876
  • Silver HJ, Olson D, Mayfield D, Wright P, Nian H, Mashayekhi M, Koethe JR, Niswender KD, Luther JM, Brown NJ. Effect of the glucagon-like peptide-1 receptor agonist liraglutide, compared to caloric restriction, on appetite, dietary intake, body fat distribution and cardiometabolic biomarkers: A randomized trial in adults with obesity and prediabetes. Diabetes Obes Metab. 2023 Aug;25(8):2340-2350. doi: 10.1111/dom.15113. Epub 2023 May 15. PMID 37188932
  • Results publication: Damluji AA, Alfaraidhy M, AlHajri N, Rohant NN, Kumar M, Al Malouf C, Bahrainy S, Ji Kwak M, Batchelor WB, Forman DE, Rich MW, Kirkpatrick J, Krishnaswami A, Alexander KP, Gerstenblith G, Cawthon P, deFilippi CR, Goyal P. Sarcopenia and Cardiovascular Diseases. Circulation. 2023 May 16;147(20):1534-1553. doi: 10.1161/CIRCULATIONAHA.123.064071. Epub 2023 May 15. PMID 37186680