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

NCT07270497 | Recruiting

• 1 other identifier: KB/136/2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GLP-1; Nutrition

Outcome Measures

Primary Outcomes (1)

• change in body weight

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

  12 months

Secondary Outcomes (31)

• Change in lean body mass

  12 months

• Change in total fat mass

  12 months

• Change in percent body fat

  12 months

• Change in HbA1c

  12 months

• Change in fasting plasma glucose

  12 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Klinika Diabetologii i Chorób Wewnętrznych Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego

Warsaw, Warszawa, 02-097, Poland

RECRUITING

Central Study Contacts

Leszek Czupryniak, professor

CONTACT

602245254; leszek.czupryniak@wum.edu.pl

Maja Sosnowska, master

CONTACT

696665002; maja.sosonowska@wum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 8, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

PL (1)