Body Composition Changes After Initiation of GLP-1 Receptor Agonists in Adults With Obesity or Type 2 Diabetes

NCT07835360 | Recruiting

• 1 other identifier: UIE-6056-26-29-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Researchers want to understand what happens to muscle and fat in the body after adults with obesity and/or type 2 diabetes start taking a GLP-1 receptor agonist medication (GLP-1RA), a type of drug already approved and commonly prescribed for weight loss and blood sugar control. This is not a drug trial. No experimental medication will be given. Instead, the study will follow people who are already starting this treatment or having their dose adjusted, as part of their regular medical care, and it will not change or interfere with any decision made by the participant's own doctor. These medications help people lose weight, but not all weight loss is the same. Some of it can come from muscle instead of fat, and losing muscle can affect strength and daily function over time. This study will use a scan called DXA (dual-energy X-ray absorptiometry.) to measure how much muscle and fat change over about one year, along with tests of grip strength, walking speed, and everyday physical performance. About 168 adults will take part at two centers in Mexico: the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán in Mexico City and the Instituto de Diabetes, Obesidad y Nutrición in Cuernavaca. After an initial visit, participants will have a phone check-in at 12 weeks and follow-up visits at 24 and 52 weeks, including blood tests, body measurements, and short questionnaires about diet, physical activity, and muscle health. Some participants may also choose to give an extra blood sample for optional genetic testing; this is voluntary and does not affect participation in the main study. There is no placebo, randomization, cost, or payment involved. All treatment decisions remain with the participant's own physician. By observing these changes under real-world conditions, the study aims to help doctors better protect muscle while patients lose fat during treatment with these medications.

Conditions

Obesity (Disorder); Type 2 Diabetes Mellitus

Keywords

GLP-1 receptor agonists; Body composition; Appendicular lean mass; DXA; Real-world evidence; Muscle strength; Visceral adipose tissue; Tirzepatide

Outcome Measures

Primary Outcomes (2)

• Change in Appendicular Lean Mass

  Change in appendicular lean mass, measured in kilograms by dual energy X-ray absorptiometry (DXA).

  Baseline, 24 weeks, and 52 weeks

• Change in Appendicular Skeletal Muscle Index (ASMI)

  Change in the appendicular skeletal muscle index, calculated as appendicular lean mass divided by height squared (kg/m²), measured by DXA.

  Baseline, 24 weeks, and 52 weeks

Secondary Outcomes (16)

• Change in Total Fat Mass

  Baseline, 24 weeks, and 52 weeks

• Change in Body Fat Percentage

  Baseline, 24 weeks, and 52 weeks

• Change in Visceral Adipose Tissue (VAT)

  Baseline, 24 weeks, and 52 weeks

• Change in Body Weight

  Baseline, 24 weeks, and 52 weeks

• Change in Body Mass Index (BMI)

  Baseline, 24 weeks, and 52 weeks

Study Arms (1)

Adults Initiating GLP-1-Based Therapy

Adults with obesity and/or type 2 diabetes who are starting GLP-1 receptor agonist therapy, or who are in the early phase of dose titration at the time of enrollment, based on the eligibility criteria defined in the protocol. Participants are followed prospectively for 52 weeks. The choice of treatment, dose adjustments, and overall clinical management are made by the treating physician as part of routine clinical care, and are not assigned by the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults with obesity and/or type 2 diabetes treated at two clinical research sites in Mexico, the Unidad de Investigación de Enfermedades Metabólicas at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán in Mexico City, and the Instituto de Diabetes, Obesidad y Nutrición in Cuernavaca. Potential participants are identified through institutional clinical databases, electronic medical records, clinic appointment schedules, and institutional social media at each site. Eligible participants are adults 18 years of age or older with a documented diagnosis of obesity and/or type 2 diabetes whose treating physician has indicated, as part of routine clinical care, a therapy with activity on the GLP-1 receptor, including GLP-1 receptor monoagonists, dual GIP/GLP-1 coagonists, or other multiple coagonists with current health authorization for clinical use in Mexico. Participants enter the study either by starting an eligible therapy during the

You may qualify if:

• Agrees to participate in the study by signing informed consent
• Age 18 years or older
• Diagnosis of obesity and/or type 2 diabetes mellitus, documented in the clinical record
• Receiving, on indication of the treating physician and as part of routine clinical care, a therapy with activity on the GLP-1 receptor, including a) GLP-1 receptor monoagonists, b) dual GIP/GLP-1 coagonists, or c) other multiple coagonists with activity on the GLP-1 receptor holding current health authorization for clinical use in Mexico
• Meeting one of the following conditions at the time of recruitment: a) starting an eligible therapy during the recruitment period, or b) being in an active dose titration phase, with an upward dose escalation documented by the treating physician, even if treatment started four or more weeks earlier, provided the participant has not yet reached a stable maintenance dose
• Willingness and ability to attend follow up evaluations at 24 weeks (plus or minus 3 weeks) and 52 weeks (plus or minus 6 weeks)

You may not qualify if:

• Diagnosis of type 1 diabetes or other specific forms of diabetes
• Pregnancy or breastfeeding at the time of recruitment
• Conditions that limit adequate measurement of body composition by DXA, including body weight above the equipment's technical limit of 159 kg, the presence of metallic devices or materials that interfere with the measurement, or having undergone a radiologic contrast study within the 7 days before the evaluation
• Acute illness at the time of recruitment that could interfere with the study evaluations or with longitudinal follow up, including hospitalization within the 4 weeks before the baseline visit, active pneumonia, acute COVID-19 infection, diabetic ketoacidosis, or major surgery within the 6 weeks before recruitment
• Chronic diseases or conditions associated with severe alterations in body composition, such as active cancer, active systemic inflammatory disease, advanced heart failure, or kidney disease on replacement therapy
• Current or recent use, within 3 months, of systemic corticosteroids at chronic pharmacologic doses or medications with a direct modulating effect on muscle mass
• Current or recent use, within 3 months before the index date, of weight loss medications other than GLP-1RA, such as phentermine, topiramate, or naltrexone/bupropion
• Simultaneous participation in a double blind randomized clinical trial

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (2)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Instituto de Diabetes, Obesidad y Nutrición, S.C

Mexico City, Mexico City, 62250, Mexico

RECRUITING

Related Publications (14)

• Vozza A, Triggiani D, Fanelli M, Lisco G, Coletto D, Custodero C, Volpe S, Racaniello D, Colaianni V, Lavarra V, Maggipinto R, Portacci A, Tortorella C, Moschetta A, Piazzolla G. Predictive factors of body weight loss in patients with type 2 diabetes treated with GLP-1 receptor agonists: a 52-week prospective real-life study. Front Endocrinol (Lausanne). 2025 Sep 25;16:1674308. doi: 10.3389/fendo.2025.1674308. eCollection 2025.

  PMID: 41079186 BACKGROUND

• Su QJ, Ashenhurst JR, Xu W, Tran V, Ryanne Wu R, Weldon CH, Shi J, Hicks B; 23andMe Research Team; Abul-Husn NS, Aslibekyan S, Holmes MV, Koelsch BL, Auton A. Genetic predictors of GLP1 receptor agonist weight loss and side effects. Nature. 2026 May;653(8115):770-775. doi: 10.1038/s41586-026-10330-z. Epub 2026 Apr 8.

  PMID: 41951734 BACKGROUND

• Gleason PP, Urick BY, Marshall LZ, Friedlander N, Qiu Y, Leslie RS. Real-world persistence and adherence to glucagon-like peptide-1 receptor agonists among obese commercially insured adults without diabetes. J Manag Care Spec Pharm. 2024 Aug;30(8):860-867. doi: 10.18553/jmcp.2024.23332. Epub 2024 May 8.

  PMID: 38717042 BACKGROUND

• McCrimmon RJ, Catarig AM, Frias JP, Lausvig NL, le Roux CW, Thielke D, Lingvay I. Effects of once-weekly semaglutide vs once-daily canagliflozin on body composition in type 2 diabetes: a substudy of the SUSTAIN 8 randomised controlled clinical trial. Diabetologia. 2020 Mar;63(3):473-485. doi: 10.1007/s00125-019-05065-8. Epub 2020 Jan 2.

  PMID: 31897524 BACKGROUND

• Look M, Dunn JP, Kushner RF, Cao D, Harris C, Gibble TH, Stefanski A, Griffin R. Body composition changes during weight reduction with tirzepatide in the SURMOUNT-1 study of adults with obesity or overweight. Diabetes Obes Metab. 2025 May;27(5):2720-2729. doi: 10.1111/dom.16275. Epub 2025 Feb 25.

  PMID: 39996356 BACKGROUND

• Eisa N, Barood O. Lean Mass Changes With Incretin Therapy Versus Lifestyle Intervention: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Diabetes Obes Metab. 2026 Jun;28(6):4818-4827. doi: 10.1111/dom.70666. Epub 2026 Mar 24.

  PMID: 41877354 BACKGROUND

• American Diabetes Association Professional Practice Committee for Diabetes*. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2026. Diabetes Care. 2026 Jan 1;49(Suppl 1):S183-S215. doi: 10.2337/dc26-S009.

  PMID: 41358900 BACKGROUND

• American Diabetes Association Professional Practice Committee for Diabetes*. 8. Obesity and Weight Management for the Prevention and Treatment of Diabetes: Standards of Care in Diabetes-2026. Diabetes Care. 2026 Jan 1;49(Suppl 1):S166-S182. doi: 10.2337/dc26-S008.

  PMID: 41358882 BACKGROUND

• Yang W, Wu H, Cai X, Lin C, Luo Y, Hu S, Li Z, Jiao R, Bai S, Liu G, Yang X, Ji L. Weight reduction and the risk of gallbladder and biliary disease: A systematic review and meta-analysis of randomized clinical trials. Obes Rev. 2024 Jun;25(6):e13725. doi: 10.1111/obr.13725. Epub 2024 Feb 12.

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• He L, Wang J, Ping F, Yang N, Huang J, Li Y, Xu L, Li W, Zhang H. Association of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Intern Med. 2022 May 1;182(5):513-519. doi: 10.1001/jamainternmed.2022.0338.

  PMID: 35344001 BACKGROUND

• Thomsen RW, Mailhac A, Lohde JB, Pottegard A. Real-world evidence on the utilization, clinical and comparative effectiveness, and adverse effects of newer GLP-1RA-based weight-loss therapies. Diabetes Obes Metab. 2025 Apr;27 Suppl 2(Suppl 2):66-88. doi: 10.1111/dom.16364. Epub 2025 Apr 8.

  PMID: 40196933 BACKGROUND

• Khan MS, Dawood MH, Handelsman Y, Anker SD, Stewart Coats AJ, Green JB, Butler J. Fat, muscle, and anti-obesity medications in cardiovascular disease prevention. Eur Heart J. 2026 Jun 2;47(21):2584-2605. doi: 10.1093/eurheartj/ehag201.

  PMID: 41914150 BACKGROUND

• Rosen CJ, Ingelfinger JR. GLP-1 Receptor Agonists. N Engl J Med. 2026 Apr 2;394(13):1313-1324. doi: 10.1056/NEJMra2500106.

  PMID: 41931049 BACKGROUND

• Reyes-Garcia A, Basto-Abreu A, Reyes-Sanchez F, Stern D, Romero-Martinez M, Campos-Nonato I, Rojas-Martinez R, Aguilar-Salinas CA, Barrientos-Gutierrez T. Prevalencia de diabetes y control glucemico en Mexico, Ensanut 2021-2024. Salud Publica Mex. 2025 Nov 22;67(6 (nov-dic)):622-632. doi: 10.21149/17286. Spanish.

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are collected from participants during the study visits for biochemical and metabolic testing. Serum and plasma may be kept refrigerated or frozen for analyses related to the study objectives. At the baseline visit, participants who give specific consent for genetic analysis will have one additional blood sample collected. This sample may be used to extract and store DNA for analyses related to body composition, obesity, type 2 diabetes, and response to treatment with GLP-1 receptor agonists.

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 22, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)