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Recruiting NCT05340868

Genetics of the Acute Response to Oral Semaglutide

Trial Parameters

Condition PreDiabetes
Sponsor Medical University of Bialystok
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2022-09-01
Completion 2025-12-31
Interventions
Semaglutide Pill

Brief 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 Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Patients diagnosed with a serious chronic disease, including: * Ischemic heart disease * Heart failure (NYHA class III-IV) * Severe renal insufficiency (eGFR \<30 ml/min) * Severe liver diseases * Inflammatory bowel disease * Diabetic gastroparesis * Cancer - currently or in the last five years prior to screening * Chronic obstructive pulmonary disease * History of mental illness, major depression or other severe mental disorders * Use of any medications with clinically-proven significant weight gain or loss effects * History of undergoing bariatric surgery or other surgery involving the stomach that could affect the absorption of the study drug (according to the investigator's opinion) * Histo

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