Genetic, Microbiological and Behavioral Factors in Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorJan Kochanowski University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years
Consent to participate in the study and providing informed written consent
Overweight or obese with a BMI >27
Disqualifiers
Type 1 or type 2 diabetes
Pregnancy or breastfeeding
Cancer
Heart failure
Trial population
Patients who are overweight or obese and were prescribed tirzepatide for their treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
genetic polymorphism
Diagnostic testGLP1 RA and GIP R polymorphisms will be assesed from venous blood samples
gut microbiome
Diagnostic teststool samples and oral cavity swabs for gut microbiome will be collected to assess V3 and V4 of gene 16s rRNA
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: patients with BMI>272 interventions
Trial outcomes
Primary outcomes
1
weight change
weight change measured in kg and as BMI
Time frame
1 and 6 monthsSecondary outcomes
1
treatment discontinuation
number of patients who discontinue treatment prematurely
Time frame
up to 6 months2
adverse reactions
any adverse gastrointestinal events and complications associated with tirzepatide treatment - frequency and intensity
Time frame
up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jan Kochanowski University
Lead sponsor
LUX MED Group
Collaborator
Source ClinicalTrials.gov