Genetics of the Acute Response to Oral Semaglutide

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedical University of Bialystok

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Ischemic heart disease

Heart failure (NYHA class III-IV)

Severe renal insufficiency (eGFR <30 ml/min)

Severe liver diseases

Trial design

Treatments tested in this trial

  • Semaglutide Pill

Treatment groups

1,000 Participants
are divided into 1 treatment group

Locations

1
Clinical Research Centre, Medical University of Bialystok15-276, BialystokPodlaskie Voivodeship, Poland

Sponsors and collaborators

Medical University of Bialystok

Lead sponsor