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GLP-1NCT07270497

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

An observational study of GLP-1 and Nutrition, run by Medical University of Warsaw at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
GLP-1, Nutrition
How many people
100 participants
Where
1 sitePoland
Study dates
15 Aug 2025to 14 Aug 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Leszek Czupryniak, professor contact

602245254

leszek.czupryniak@wum.edu.pl

Maja Sosnowska, master contact

696665002

maja.sosonowska@wum.edu.pl

Poland1 site, 1 recruiting
  • Klinika Diabetologii i Chorób Wewnętrznych Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego

    Warsaw, Warszawa, 02-097

    Leszek Czupryniak, professor, 602245254, leszek.czupryniak@wum.edu.pl

    Maja Sosnowska, master, 696665002, maja.sosnowska@wum.edu.pl

    Recruiting

Other trials in Poland

About this study

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in body weight

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

    Measured: 12 months

Secondary outcomes (31)
  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).

    Measured: 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).

    Measured: 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 (%).

    Measured: 12 months

  4. Change in HbA1c

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

    Measured: 12 months

  5. Change in fasting plasma glucose

    Change in fasting plasma glucose measured using enzymatic laboratory assay. Reported in mmol/L (or mg/dL).

    Measured: 12 months

  6. Change in fasting insulin concentration

    Change in fasting insulin measured using immunoassay (e.g., ELISA/chemiluminescence). Reported in μU/mL.

    Measured: 12 months

  7. Change in HOMA-IR

    Change in insulin resistance calculated using HOMA-IR (fasting insulin × fasting glucose / 22.5).

    Measured: 12 months

  8. 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).

    Measured: 12 months

  9. Change in liver enzymes and creatinine

    Change in ALT, AST (U/L) and serum creatinine (µmol/L) measured using standard laboratory methods.

    Measured: 12 months

  10. 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

    Measured: 12 months

  11. Change in diabetes treatment

    Number and percentage of participants with changes in diabetes pharmacotherapy (dose modification, medication initiation/discontinuation, or class switch).

    Measured: 12 months

  12. Change in antihypertensive treatment

    Number and percentage of participants with changes in antihypertensive therapy (dose adjustment, medication initiation/discontinuation, or class switch).

    Measured: 12 months

  13. 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.

    Measured: 12 months

  14. 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.

    Measured: 12 months

  15. 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.

    Measured: 12 months

  16. 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.

    Measured: 12 months

  17. 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.

    Measured: 12 months

  18. 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.

    Measured: 12 months

  19. Change in uncontrolled eating score (TFEQ-R18)

    Change in uncontrolled eating assessed using TFEQ-R18. Higher scores indicate greater susceptibility to uncontrolled eating.

    Measured: 12 months

  20. Change in cognitive restraint score (TFEQ-R18)

    Change in cognitive restraint (intentional food restriction) assessed using TFEQ-R18. Higher scores indicate higher restraint.

    Measured: 12 months

  21. 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

    Measured: 12 months

  22. Change in subjective satiety (VAS)

    Change in subjective satiety measured using VAS (0-100 mm). Higher scores indicate greater satiety.

    Measured: 12 months

  23. 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.

    Measured: 12 months

  24. Change in preference for high-fat foods (VAS)

    Change in desire to consume high-fat foods measured using VAS (0-100 mm).

    Measured: 12 months

  25. Change in preference for salty foods (VAS)

    Change in desire to consume salty foods measured using VAS (0-100 mm).

    Measured: 12 months

  26. Change in preference for meat-based products (VAS)

    Change in desire to consume meat-based foods measured using VAS (0-100 mm).

    Measured: 12 months

  27. 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).

    Measured: 12 months

  28. 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.

    Measured: 12 months

  29. Change in meal frequency

    Change in number of daily eating occasions based on the 3-day food record. Reported as meals/day.

    Measured: 12 months

  30. 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.

    Measured: 12 months

  31. 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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start15 Aug 2025
  3. Primary completion14 Aug 2026 (estimated)
  4. Study completion14 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07270497
Sponsor's protocol ID
KB/136/2025
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of GLP-1 and Nutrition, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leszek Czupryniak, professor (602245254, leszek.czupryniak@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in body weight (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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