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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Adults Initiating GLP-1-Based Therapy

Trial outcomes

Primary outcomes

1

Change in Appendicular Lean Mass

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

Time frame
Baseline, 24 weeks, and 52 weeks
2

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.

Time frame
Baseline, 24 weeks, and 52 weeks

Secondary outcomes

1

Change in Total Fat Mass

Change in total body fat mass, measured in kilograms by DXA.

Time frame
Baseline, 24 weeks, and 52 weeks
2

Change in Body Fat Percentage

Change in body fat percentage, measured by DXA.

Time frame
Baseline, 24 weeks, and 52 weeks
3

Change in Visceral Adipose Tissue (VAT)

Change in visceral fat mass, measured by DXA.

Time frame
Baseline, 24 weeks, and 52 weeks
4

Change in Body Weight

Change in body weight, measured in kilograms.

Time frame
Baseline, 24 weeks, and 52 weeks

Other outcomes

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