Genetics of the Acute Response to Oral Semaglutide

Sponsor
Medical University of Bialystok
Study ID
NCT05340868
Status
Recruiting
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Conditions

  • Obesity
  • PreDiabetes
  • Prediabetic State

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Semaglutide (oral)
    In this study, each participant will receive a regimen of oral semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, for a duration of twelve weeks. The dosage will begin at 3 mg/day for weeks 1-2, gradually increasing to 7 mg/day for weeks 3-4, 14 mg/day for weeks 5-6, 28 mg/day for weeks 7-8, and finally, to 42 mg/day for the last four weeks (weeks 9-12).

Primary Outcome Measure

Glycemic measures - change in HbA1c (%) [ Time Frame: 1 and 3 months ]

Central Contacts

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