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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Semaglutide Pill
DrugOral semaglutide treatment
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Semaglutide (oral)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Glycemic measures - change in HbA1c (%)
Investigators will measure the change in HbA1c concentration between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Time frame
1 and 3 months2
Body composition - change in body weight (kg)
Investigators will measure the change in body weight measures between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Time frame
1 and 3 monthsSecondary outcomes
1
Glycemic measures - change in 2-hour glucose (in mg/dl)
Investigators will measure the change in 2-hour glucose measures (OGTT) between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Time frame
1 and 3 months2
Glycemic measures - change in fasting glucose (in mg/dl)
Investigators will measure the change in fasting glucose measures between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Time frame
1 and 3 months3
Body composition - change in body fat content (kg)
Investigators will measure the change in body fat content between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Time frame
1 and 3 months4
Body composition - change in lean body mass content (kg)
Investigators will measure the change in lean body mass content between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Time frame
1 and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov