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

November 25, 2025 updated by: Medical University of Warsaw
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
    • Warszawa
      • Warsaw, Warszawa, Poland, 02-097
        • Recruiting
        • Klinika Diabetologii i Chorób Wewnętrznych Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in body weight
Time Frame: 12 months
percentage change in body weight from baseline to the end of follow-up
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in lean body mass
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
Change in hemoglobin A1c measured in venous blood using standard laboratory HPLC assay. Reported as percent (%).
12 months
Change in fasting plasma glucose
Time Frame: 12 months
Change in fasting plasma glucose measured using enzymatic laboratory assay. Reported in mmol/L (or mg/dL).
12 months
Change in fasting insulin concentration
Time Frame: 12 months
Change in fasting insulin measured using immunoassay (e.g., ELISA/chemiluminescence). Reported in μU/mL.
12 months
Change in HOMA-IR
Time Frame: 12 months
Change in insulin resistance calculated using HOMA-IR (fasting insulin × fasting glucose / 22.5).
12 months
Change in lipid profile
Time Frame: 12 months
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
Time Frame: 12 months
Change in ALT, AST (U/L) and serum creatinine (µmol/L) measured using standard laboratory methods.
12 months
Change in daily energy intake
Time Frame: 12 months
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
Time Frame: 12 months
Number and percentage of participants with changes in diabetes pharmacotherapy (dose modification, medication initiation/discontinuation, or class switch).
12 months
Change in antihypertensive treatment
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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)
Time Frame: 12 months
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
Time Frame: 12 months
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)
Time Frame: 12 months
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)
Time Frame: 12 months
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)
Time Frame: 12 months
Change in cognitive restraint (intentional food restriction) assessed using TFEQ-R18. Higher scores indicate higher restraint.
12 months
Change in subjective hunger (VAS)
Time Frame: 12 months
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)
Time Frame: 12 months
Change in subjective satiety measured using VAS (0-100 mm). Higher scores indicate greater satiety.
12 months
Change in sweet taste preference (VAS)
Time Frame: 12 months
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)
Time Frame: 12 months
Change in desire to consume high-fat foods measured using VAS (0-100 mm).
12 months
Change in preference for salty foods (VAS)
Time Frame: 12 months
Change in desire to consume salty foods measured using VAS (0-100 mm).
12 months
Change in preference for meat-based products (VAS)
Time Frame: 12 months
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)
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 14, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings