Genetics of the Acute Response to Oral Semaglutide (GAROS)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• Informed consent was given before any study-related action on the subject.

• Age: 18-65 years old

• Body mass index (BMI) \>30 kg/m2 or \>27 kg/m2 when accompanied by prediabetes, diagnosed according to the criteria of the American Diabetes Association

Locations
Other Locations
Poland
Clinical Research Centre, Medical University of Bialystok
RECRUITING
Bialystok
Contact Information
Primary
Lukasz Szczerbinski, MD, PhD
lukasz.szczerbinski@umb.edu.pl
+48858318150
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1000
Treatments
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).
Sponsors
Leads: Medical University of Bialystok

This content was sourced from clinicaltrials.gov