ObesityGLP1-SARCONCT07858864
GLP-1 Receptor Agonist Use and Sarcopenia in Obese Individuals Without Diabetes
An observational study of Obesity and Sarcopenia, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Sarcopenia
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2026to 30 Nov 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, Kucukcekmece
gülden ANATACA, 5059284244, ganataca@yahoo.com
About this study
Official title: Evaluation of the Relationship Between GLP-1 Receptor Agonist Use and Sarcopenia in Non-Diabetic Obese Individuals: A Prospective Descriptive Study
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.
Read the 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.
- Conditions
- Obesity, Sarcopenia
- Being tested
- GLP-1 receptor agonist (e.g., semaglutide, tirzepatide) - prescribed by the treating physician as standard care; the study does not assign or alter treatment.
- Keywords
- GLP-1 receptor agonist, Sarcopenia, Sarcopenic obesity, SARC-F Handgrip strength
- Medical subject headings
- Obesity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic obese adults receiving a GLP-1 RA (or GLP-1/GIP dual agonist) for obesity | 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. Receives: Drug: GLP-1 receptor agonist (e.g., semaglutide, tirzepatide) - prescribed by the treating physician as standard care; the study does not assign or alter treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (GLP-1 RA initiation) and 3 months
Secondary 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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start30 May 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜLDEN ANATACA, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858864
- Sponsor's protocol ID
- KAEWZ026.06.227
- Acronym
- GLP1-SARCO
- Status last verified
- May 2026
- First submitted
- 29 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36700417Sargeant 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.
PubMed 31565876Silver 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.
PubMed 37188932Damluji 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.
PubMed 37186680
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between GLP-1 Receptor Agonist Use and Sarcopenia in Non-Diabetic Obese Individuals: A Prospective Descriptive Study
- ClinicalTrials.gov ID
- NCT07858864
- Acronym / sponsor ID
- GLP1-SARCO / KAEWZ026.06.227
- Conditions
- Obesity, Sarcopenia
- Keywords
- GLP-1 receptor agonist, Sarcopenia, Sarcopenic obesity, SARC-F Handgrip strength
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 30 May 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic obese adults receiving a GLP-1 RA (or GLP-1/GIP dual agonist) for obesity | – | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 receptor agonist (e.g., semaglutide, tirzepatide) - prescribed by the treating physician as standard care; the study does not assign or alter treatment.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. | Drug | Non-diabetic obese adults receiving a GLP-1 RA (or GLP-1/GIP dual agonist) for obesity |
Primary outcome
Change in SARC-F (Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls) total score
Time frame: 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.
1 secondary outcome
Number of participants with a positive SARC-F screening result
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 36700417Aroda 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.
- Background: PubMed 31565876Sargeant 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.
- Background: PubMed 37188932Silver 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.
- Results publication: PubMed 37186680Damluji 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Sarcopenia, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GÜLDEN ANATACA (05059284244, ganataca@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SARC-F (Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls) total score (time frame: Baseline (GLP-1 RA initiation) and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07858864, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.