Genetic, Microbiological and Behavioral Factors in Obesity

Jan Kochanowski University200 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Obesity & Overweight Obesity Genetics

Interventions

genetic polymorphismDIAGNOSTIC_TEST

GLP1 RA and GIP R polymorphisms will be assesed from venous blood samples

gut microbiomeDIAGNOSTIC_TEST

stool samples and oral cavity swabs for gut microbiome will be collected to assess V3 and V4 of gene 16s rRNA

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria * Age 18-65 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

Locations (2)

Waga Zmiany

Krakow, Poland

RECRUITING

Luxmed sp zoo

Warsaw, Poland

RECRUITING

Outcomes

Primary Outcomes

weight change

weight change measured in kg and as BMI

Time frame: 1 and 6 months

Secondary Outcomes

treatment discontinuation

number of patients who discontinue treatment prematurely

Time frame: up to 6 months

adverse reactions

any adverse gastrointestinal events and complications associated with tirzepatide treatment - frequency and intensity

Time frame: up to 6 months

Central Contacts

Zbigniew Siudak PI, MD, PhD

CONTACT

+48 41 349 6972 zbigniew.siudak@ujk.edu.pl

Data from ClinicalTrials.gov

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