Genetics of the Acute Response to Oral Semaglutide (GAROS)

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Bialystok

Criteria

Inclusion Criteria:

• Informed consent was given before any study-related action on the subject.

• Age: 18-65 years old

• Body mass index (BMI) 30-43 kg/m2

• 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)

• History of idiopathic acute pancreatitis

• A family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer

• For women - pregnancy, breastfeeding or planning pregnancy.

• Women of childbearing age who are not using highly effective methods of contraception

• Known or suspected hypersensitivity to the test product