Effects of GLP-1 and GIP/GLP-1 medications on diet, metabolism, and behavior in adults with excess weight

The Effect of Pharmacotherapy With GLP-1 and GIP/GLP-1 Analogs on Changes in Qualitative and Quantitative Parameters of the Diet as Well as Metabolic and Behavioral Parameters in Patients With Excess Body Weight

This project will test whether GLP-1 and GIP/GLP-1 medications change eating habits, weight, metabolism, and related behaviors in adults with overweight or obesity.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Medical University of Warsaw (Academic / other)
• Locations: 1 site (Warsaw, Warszawa)
• Trial ID: NCT07270497 on ClinicalTrials.gov

What this trial studies

This observational study will follow adults starting treatment with GLP-1 or GIP/GLP-1 analogues and collect data before treatment and at 3, 6, and 12 months. Researchers will measure weight, body composition, biochemical markers, and detailed dietary intake to capture both quantitative and qualitative changes in eating. The protocol also tracks appetite regulation, risk of malnutrition and muscle loss, and any adverse events to provide a holistic view of treatment effects. Data will be collected at four clinic visits at the Clinic of Diabetology and Internal Medicine, Medical University of Warsaw.

Who should consider this trial

Good fit: Adults aged 18–65 with BMI ≥30 kg/m² or BMI ≥27 kg/m² with weight-related comorbidities who are eligible for and not recently treated with GLP-1 or GIP/GLP-1 analogues are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have active cancer, certain gastrointestinal disorders, prior bariatric surgery, diagnosed eating disorders, or cannot attend regular clinic visits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the results could help doctors tailor GLP-1 and GIP/GLP-1 treatments to maximize healthy weight loss while reducing risks like malnutrition or muscle loss.

How similar studies have performed: Previous clinical trials of GLP-1 and combined GIP/GLP-1 agents have produced substantial weight loss and metabolic improvements, but the specific effects on diet composition, appetite behavior, and muscle loss over time remain less well characterized.

Eligibility criteria

Inclusion Criteria:

* Age 18-65 years,
* Diagnosed obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with comorbidities associated with excess body weight (including type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease),
* Eligibility for treatment with GLP-1 or GIP/GLP-1 analogues,
* Not taking GLP-1 and GIP/GLP-1 analogue medications for at least one year prior to study enrollment,
* Ability to provide informed consent,
* Informed consent to participate in the study.

Exclusion Criteria:

* Age under 18 or over 65 years,
* Inability to qualify for treatment with GLP-1 and GIP/GLP-1 analogues,
* Pregnancy or breastfeeding,
* Diagnosed eating disorders,
* Active cancer or gastrointestinal conditions that may affect the absorption or tolerance of treatment (e.g., inflammatory bowel disease, conditions after extensive gastrointestinal resections, conditions after bariatric surgery),
* Inability to participate in regular follow-up visits,
* Inability to provide informed consent,
* Failure to provide informed consent to participate in the study.

Where this trial is running

Warsaw, Warszawa

• Klinika Diabetologii i Chorób Wewnętrznych Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego — Warsaw, Warszawa, Poland (Recruiting)

Study contacts

• Study coordinator: Leszek Czupryniak, professor

Conditions GLP-1; Nutrition