Genetic, Microbiological and Behavioral Factors in Obesity
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
- The protocol lists: genetic polymorphism, gut microbiome.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight, Obesity, Genetics. Basic parameters: 18 years — 60 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 →
Official title
OPTIMIZE GEN - Outcomes of Persistence and Treatment With tIrzepatide deterMined by Genetic, mIcrobiological & bEhavioral Factors in obEsity
Overview
This study will assess the impact of genetic markers, microbiological (microbiome) and behavioral factors on tolerance, adherence and effectiveness of dual GLP1/GIP RA in the treatment of obesity. 200 consecutive patients who meet all inclusion and none of the exclusion criteria will be enrolled.
Interventions
- Diagnostic test genetic polymorphism
GLP1 RA and GIP R polymorphisms will be assesed from venous blood samples - Diagnostic test gut microbiome
stool samples and oral cavity swabs for gut microbiome will be collected to assess V3 and V4 of gene 16s rRNA
Primary outcome measures
- weight change [Time frame: 1 and 6 months]
Secondary outcome measures (2)
- treatment discontinuation [Time frame: up to 6 months]
- adverse reactions [Time frame: up to 6 months]
Eligibility criteria
Inclusion criteria
- Age 18-60 years
- Consent to participate in the study and providing informed written consent
- Overweight or obese with a BMI >27
Exclusion criteria
- Contraindications to tirzepatide use:
- Type 1 or type 2 diabetes
- Pregnancy or breastfeeding
- Cancer
- Heart failure
- Expected lack of patient compliance
- Taking immunosuppressive medications, steroids, NSAIDs, antibiotics (within 2 weeks prior to sample collection),
- Autoimmune and inflammatory diseases, acute infectious diseases, AIDS, tuberculosis
- Mental illness
- Alcohol dependence syndrome
- Liver cirrhosis
- Post-myocardial infarction or stroke
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 · 2 centers
- Waga Zmiany — Krakow
- Luxmed sp zoo — Warsaw
Identifiers
NCT: NCT07650149 · 1/2026 of 6.05.2026