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NCT Number: NCT07270497

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinika Diabetologii i Chorób Wewnętrznych Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego

Warsaw, Warszawa, 02-097, Poland

Location status: Recruiting

Location contact

Leszek Czupryniak, professor

CONTACT

[email protected]

602245254

Maja Sosnowska, master

CONTACT

[email protected]

696665002

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. change in body weight

    Time frame: 12 months

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

Secondary outcomes

  1. 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).

  2. 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).

  3. 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 (%).

  4. Change in HbA1c

    Time frame: 12 months

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

  5. 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).

  6. Change in fasting insulin concentration

    Time frame: 12 months

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

  7. Change in HOMA-IR

    Time frame: 12 months

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

  8. 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).

  9. 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.

  10. 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

  11. 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. 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).

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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

  22. Change in subjective satiety (VAS)

    Time frame: 12 months

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

  23. 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.

  24. 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).

  25. Change in preference for salty foods (VAS)

    Time frame: 12 months

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

  26. 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).

  27. 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).

  28. 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.

  29. 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.

  30. 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.

  31. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Leszek Czupryniak, professor

CONTACT

[email protected]

602245254

Maja Sosnowska, master

CONTACT

[email protected]

696665002

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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