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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in Appendicular Lean Mass
Change in appendicular lean mass, measured in kilograms by dual energy X-ray absorptiometry (DXA).
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.
Secondary outcomes
Change in Total Fat Mass
Change in total body fat mass, measured in kilograms by DXA.
Change in Body Fat Percentage
Change in body fat percentage, measured by DXA.
Change in Visceral Adipose Tissue (VAT)
Change in visceral fat mass, measured by DXA.
Change in Body Weight
Change in body weight, measured in kilograms.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.