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

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition; GLP-1

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Leszek Czupryniak, professor; Phone Number: 602245254; Email: leszek.czupryniak@wum.edu.pl
• Study Contact Backup: Name: Maja Sosnowska, master; Phone Number: 696665002; Email: maja.sosonowska@wum.edu.pl

Study Locations

• Poland
  • Warszawa
    • Warsaw, Warszawa, Poland, 02-097
      • Recruiting
      • Klinika Diabetologii i Chorób Wewnętrznych Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego
      • Contact: Leszek Czupryniak, professor; Phone Number: 602245254; Email: leszek.czupryniak@wum.edu.pl
      • Contact: Maja Sosnowska, master; Phone Number: 696665002; Email: maja.sosnowska@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in body weight	percentage change in body weight from baseline to the end of follow-up	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months
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).	12 months
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 (%).	12 months
Change in HbA1c	Change in hemoglobin A1c measured in venous blood using standard laboratory HPLC assay. Reported as percent (%).	12 months
Change in fasting plasma glucose	Change in fasting plasma glucose measured using enzymatic laboratory assay. Reported in mmol/L (or mg/dL).	12 months
Change in fasting insulin concentration	Change in fasting insulin measured using immunoassay (e.g., ELISA/chemiluminescence). Reported in μU/mL.	12 months
Change in HOMA-IR	Change in insulin resistance calculated using HOMA-IR (fasting insulin × fasting glucose / 22.5).	12 months
Change in lipid profile	Change in total cholesterol, LDL-C, HDL-C, and triglycerides measured using standard serum laboratory assays. Reported in mmol/L (or mg/dL).	12 months
Change in liver enzymes and creatinine	Change in ALT, AST (U/L) and serum creatinine (µmol/L) measured using standard laboratory methods.	12 months
Change in daily energy intake	Change in average daily energy intake assessed from 3-day food records (2 weekdays + 1 weekend day), analyzed using a 3-day food diary	12 months
Change in diabetes treatment	Number and percentage of participants with changes in diabetes pharmacotherapy (dose modification, medication initiation/discontinuation, or class switch).	12 months
Change in antihypertensive treatment	Number and percentage of participants with changes in antihypertensive therapy (dose adjustment, medication initiation/discontinuation, or class switch).	12 months
Change in daily carbohydrate intake	Change in daily carbohydrate intake assessed using a 3-day weighed food record and analyzed with validated dietary software. Reported in grams/day and as percent of total energy intake.	12 months
Change in daily fat intake	Change in total fat intake assessed using a 3-day weighed food record. Reported in grams/day and percent of total energy intake.	12 months
Change in daily protein intake	Change in protein intake assessed using a 3-day weighed food record. Reported in grams/day and grams per kilogram of body weight.	12 months
Change in diet quality score (KomPAN)	Change in diet quality assessed using the validated KomPAN questionnaire (modified for 3-month frequency assessment). Reported as the KomPAN dietary index score, according to validated scoring rules.	12 months
Change in frequency of consumption of selected food groups	Change in the frequency of consumption of selected food groups assessed using the validated KomPAN food frequency questionnaire. Includes changes in consumption of: vegetables, fruit, whole grains, sweets, high-fat foods, meat products, sweetened beverages, and others defined in KomPAN. Reported as frequency categories or converted frequency units.	12 months
Change in emotional eating score (TFEQ-R18)	Change in emotional eating assessed with the validated Three-Factor Eating Questionnaire (TFEQ-R18). Scale range 0-100 (converted), higher scores indicate stronger emotional eating tendencies.	12 months
Change in uncontrolled eating score (TFEQ-R18)	Change in uncontrolled eating assessed using TFEQ-R18. Higher scores indicate greater susceptibility to uncontrolled eating.	12 months
Change in cognitive restraint score (TFEQ-R18)	Change in cognitive restraint (intentional food restriction) assessed using TFEQ-R18. Higher scores indicate higher restraint.	12 months
Change in subjective hunger (VAS)	Change in subjective hunger measured using a Visual Analog Scale (VAS, 0-100 mm) within the validated questionnaire set. Higher scores indicate greater hunger	12 months
Change in subjective satiety (VAS)	Change in subjective satiety measured using VAS (0-100 mm). Higher scores indicate greater satiety.	12 months
Change in sweet taste preference (VAS)	Change in desire to consume sweet foods measured using a Visual Analog Scale (VAS, 0-100 mm) as part of the custom taste preference questionnaire.	12 months
Change in preference for high-fat foods (VAS)	Change in desire to consume high-fat foods measured using VAS (0-100 mm).	12 months
Change in preference for salty foods (VAS)	Change in desire to consume salty foods measured using VAS (0-100 mm).	12 months
Change in preference for meat-based products (VAS)	Change in desire to consume meat-based foods measured using VAS (0-100 mm).	12 months
Change in preference for fresh/fruit-based foods (VAS)	Change in desire to consume fresh or fruit-based foods assessed using VAS (0-100 mm).	12 months
Change in risk of inadequate nutrient intake	Change in risk of insufficient intake of key nutrients (vitamin D, B12, folate, iron, protein) assessed indirectly through 3-day weighed food records and KomPAN questionnaire data. Reported as intake relative to recommended dietary allowances.	12 months
Change in meal frequency	Change in number of daily eating occasions based on the 3-day food record. Reported as meals/day.	12 months
Change in mean daily step count	Change in average daily number of steps recorded from the participant's smartphone health application. Step count is extracted from the app's built-in accelerometer-based activity tracking. Reported as steps per day.	12 months
Change in handgrip strength	Change in maximal handgrip strength measured using a calibrated handheld dynamometer. Strength is assessed in the dominant hand, with three attempts per measurement, and the highest value recorded. Reported in kilograms (kg).	12 months

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2025
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: KB/136/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No