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

Status

Recruiting

Phase

Phase not stated

Enrollment

200 participants (estimated)

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Other

Design

Not stated

Countries

1 country

Mexico

Start

10 Jul 2026

Primary completion

Jul 2029 (estimated)

Completion

Jul 2029 (estimated)

First posted

22 Sept 2026

Last update posted

25 Sept 2026

Conditions

Obesity (Disorder) · Type 2 Diabetes Mellitus

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.

• Other

  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.

1. Change in Appendicular Lean Mass

   Time frame · Baseline, 24 weeks, and 52 weeks

   Registry description

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

2. Change in Appendicular Skeletal Muscle Index (ASMI)

   Time frame · Baseline, 24 weeks, and 52 weeks

   Registry description

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