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Genetics of the Acute Response to Oral Semaglutide

Study acronym: GAROS
StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v5
  2. Study description revised
    • Study title shortened, about 1 word
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2022 to Sep 1, 2022
    • Eligibility criteria expanded, about 6 words
    • Site details revised
    v3
  4. Start date: May 16, 2022 to Aug 1, 2022v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05340868
Lead Sponsor Medical University of Bialystok
Conditions
(from sponsor)		 PreDiabetes, Prediabetic State, Obesity
Related terms Obesity, Prediabetic State
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov