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

ConditionsGLP-1Nutrition
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMedical University of Warsaw

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

change in body weight

percentage change in body weight from baseline to the end of follow-up

Time frame
12 months

Secondary outcomes

1

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).

Time frame
12 months
2

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).

Time frame
12 months
3

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 (%).

Time frame
12 months
4

Change in HbA1c

Change in hemoglobin A1c measured in venous blood using standard laboratory HPLC assay. Reported as percent (%).

Time frame
12 months

Other outcomes

Sponsors and contacts

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