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

Medical University of Warsaw

Status: Enrolling

Conditions: Nutrition; GLP-1

Study type: Observational

Funder types: Other

Identifiers

NCT07270497

KB/136/2025

Details and patient eligibility

About

The aim of this study is to comprehensively assess the early and long-term effects of GLP-1 and GIP/GLP-1 analogue medications on metabolic and behavioral parameters, with particular emphasis on qualitative and quantitative dietary changes in patients undergoing treatment for overweight and obesity. Participation in the study will involve four follow-up visits per year at the Clinic of Diabetology and Internal Medicine, Central Clinical Hospital, University Clinical Clinical Hospital, Medical University of Warsaw: before treatment initiation and after 3, 6, and 12 months. The analysis will focus not only on metabolic effects (weight loss, changes in body composition, and improved biochemical parameters), but also on nutritional and behavioral aspects, including diet, appetite regulation, risk of malnutrition and muscle loss, and the occurrence of adverse events. The study will allow for a multifaceted assessment of the impact of treatment with GLP-1 and GIP/GLP-1 analogues on patients with excess body weight.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.