About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial population
People diagnosed with 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), eligibilited for treatment with GLP-1 or GIP/GLP-1 analogues.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
change in body weight
percentage change in body weight from baseline to the end of follow-up
Secondary outcomes
Change in lean body mass
Change in lean body mass measured using the Tanita MC-980MA Plus segmental body composition analyzer. Reported in kilograms (kg).
Change in total fat mass
Change in total fat mass measured using the Tanita MC-980MA Plus segmental body composition analyzer (bioelectrical impedance analysis). Reported in kilograms (kg).
Change in percent body fat
Change in percent body fat measured using the Tanita MC-980MA Plus segmental body composition analyzer. Reported as percent of total body mass (%).
Change in HbA1c
Change in hemoglobin A1c measured in venous blood using standard laboratory HPLC assay. Reported as percent (%).
Sponsors and contacts
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