Clinical Trial

Genetics of the Acute Response to Oral Semaglutide

Study acronym: GAROS
Recruiting
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Record status
This record was last updated March 26, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
The study aims to investigate the genetic basis of the response to short-term (3 months) orally administered semaglutide treatment, in terms of improving metabolic parameters, including the hormonal response to a standardized meal, and changes in body composition and liver steatosis. In the study, parameters such as fasting and 2-hour glucose during OGTT, HbA1c, body fat mass, body weight, total cholesterol, HDL and LDL, triglycerides, HOMA-IR, Matsuda Index and liver steatosis will be assessed. All the patients will undergo genome-wide genotyping. Moreover, in a subset of participants, muscle and fat biopsies will be performed, before and after the treatment, and liver, muscle and pancreas fat content will be assessed using MRI.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-04-16; most recent amendment 2025-03-21.
Status change: Not Yet Recruiting → Recruiting 2022-11-02
Trial Details
NCT Number NCT05340868
Lead Sponsor Medical University of Bialystok
Conditions PreDiabetes, Prediabetic State, Obesity
Enrollment 1,000 participants
Start Date 2022-09-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-26