Body composition changes after starting GLP-1 therapies in adults with obesity or type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study in routine clinical care, not a drug trial. Participants will undergo DXA scans to measure appendicular lean mass and fat, plus tests of grip strength and mobility, over roughly 12 months. The goal is to describe patterns of body composition changes when starting or titrating GLP-1 receptor agonists used for weight management and glucose control. No experimental treatment will be given, and care decisions remain with the treating physician.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Agrees to participate in the study by signing informed consent
2. Age 18 years or older
3. Diagnosis of obesity and/or type 2 diabetes mellitus, documented in the clinical record
4. 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
5. 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
6. Willingness and ability to attend follow up evaluations at 24 weeks (plus or minus 3 weeks) and 52 weeks (plus or minus 6 weeks)

Exclusion Criteria:

1. Diagnosis of type 1 diabetes or other specific forms of diabetes
2. Pregnancy or breastfeeding at the time of recruitment
3. 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
4. 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
5. 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
6. Current or recent use, within 3 months, of systemic corticosteroids at chronic pharmacologic doses or medications with a direct modulating effect on muscle mass
7. 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
8. Simultaneous participation in a double blind randomized clinical trial

Where it's running

• Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
  Mexico City, Mexico City, Mexico Recruiting
• Instituto de Diabetes, Obesidad y Nutrición, S.C
  Mexico City, Mexico City, Mexico Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.