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Recruiting 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

— Observational GLP-1 Nutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: GLP-1, Nutrition. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • change in body weight [Time frame: 12 months]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Klinika Diabetologii i Chorób Wewnętrznych Uniwersyteckiego Centrum Klinicznego Warszawski — Warsaw

Identifiers

NCT: NCT07270497 · KB/136/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗