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.
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
- 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.
Poland1 site, 1 recruiting
- 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
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body weight
percentage change in body weight from baseline to the end of follow-up
Measured: 12 months
Secondary outcomes (31)
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
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
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
Change in HbA1c
Change in hemoglobin A1c measured in venous blood using standard laboratory HPLC assay. Reported as percent (%).
Measured: 12 months
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
Change in fasting insulin concentration
Change in fasting insulin measured using immunoassay (e.g., ELISA/chemiluminescence). Reported in μU/mL.
Measured: 12 months
Change in HOMA-IR
Change in insulin resistance calculated using HOMA-IR (fasting insulin × fasting glucose / 22.5).
Measured: 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).
Measured: 12 months
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
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
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
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
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
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
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
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
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
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
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
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
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
Change in subjective satiety (VAS)
Change in subjective satiety measured using VAS (0-100 mm). Higher scores indicate greater satiety.
Measured: 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.
Measured: 12 months
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
Change in preference for salty foods (VAS)
Change in desire to consume salty foods measured using VAS (0-100 mm).
Measured: 12 months
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
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
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
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
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
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.
- First posted8 Dec 2025
- Study start15 Aug 2025
- Primary completion14 Aug 2026 (estimated)
- Study completion14 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLP-1Studies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07270497
- Acronym / sponsor ID
- KB/136/2025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 14 Aug 2026 (estimated)
- Study completion
- 14 Aug 2026 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in body weight
Time frame: 12 months
percentage change in body weight from baseline to the end of follow-up
31 secondary outcomes
Change in lean body mass
Time frame: 12 months
Change in total fat mass
Time frame: 12 months
Change in percent body fat
Time frame: 12 months
Change in HbA1c
Time frame: 12 months
Change in fasting plasma glucose
Time frame: 12 months
Change in fasting insulin concentration
Time frame: 12 months
Change in HOMA-IR
Time frame: 12 months
Change in lipid profile
Time frame: 12 months
Change in liver enzymes and creatinine
Time frame: 12 months
Change in daily energy intake
Time frame: 12 months
Change in diabetes treatment
Time frame: 12 months
Change in antihypertensive treatment
Time frame: 12 months
Change in daily carbohydrate intake
Time frame: 12 months
Change in daily fat intake
Time frame: 12 months
Change in daily protein intake
Time frame: 12 months
Change in diet quality score (KomPAN)
Time frame: 12 months
Change in frequency of consumption of selected food groups
Time frame: 12 months
Change in emotional eating score (TFEQ-R18)
Time frame: 12 months
Change in uncontrolled eating score (TFEQ-R18)
Time frame: 12 months
Change in cognitive restraint score (TFEQ-R18)
Time frame: 12 months
Change in subjective hunger (VAS)
Time frame: 12 months
Change in subjective satiety (VAS)
Time frame: 12 months
Change in sweet taste preference (VAS)
Time frame: 12 months
Change in preference for high-fat foods (VAS)
Time frame: 12 months
Change in preference for salty foods (VAS)
Time frame: 12 months
Change in preference for meat-based products (VAS)
Time frame: 12 months
Change in preference for fresh/fruit-based foods (VAS)
Time frame: 12 months
Change in risk of inadequate nutrient intake
Time frame: 12 months
Change in meal frequency
Time frame: 12 months
Change in mean daily step count
Time frame: 12 months
Change in handgrip strength
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.