Genetic, Microbiological and Behavioral Factors in Obesity

NCT07650149 | Recruiting

• 1 other identifier: 1/2026 of 6.05.2026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Genetics; Obesity & Overweight; Obesity

Keywords

tirzepatide; obesity; genetics; microbiom; adherence; compliance; gene

Outcome Measures

Primary Outcomes (1)

• weight change

  weight change measured in kg and as BMI

  1 and 6 months

Secondary Outcomes (2)

• treatment discontinuation

  up to 6 months

• adverse reactions

  up to 6 months

Study Arms (1)

patients with BMI>27

tirzepatide treatment

Diagnostic Test: genetic polymorphism; Diagnostic Test: gut microbiome

Interventions

genetic polymorphism DIAGNOSTIC_TEST

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

patients with BMI>27

gut microbiome DIAGNOSTIC_TEST

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

patients with BMI>27

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are overweight or obese and were prescribed tirzepatide for their treatment

You may qualify if:

• Age 18-60 years
• Consent to participate in the study and providing informed written consent
• Overweight or obese with a BMI \>27

You may not qualify if:

• 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

Sponsors & Collaborators

• Jan Kochanowski University: lead
• LUX MED Group: collaborator

Study Sites (2)

Waga Zmiany

Krakow, Poland

RECRUITING

Luxmed sp zoo

Warsaw, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

venous blood, stool samples and oral cavity swabs

MeSH Terms

Conditions

Obesity; Overweight; Patient Compliance

Interventions

Polymorphism, Genetic; Gastrointestinal Microbiome

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Genetic Variation; Genetic Phenomena; Microbiota; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Central Study Contacts

Zbigniew Siudak PI, MD, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: May 23, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

PL (2)