Obesity Clinical Trial
— GAROSOfficial title:
Genetics of the Acute Response to Oral Semaglutide (GAROS)
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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) - 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Clinical Research Centre, Medical University of Bialystok | Bialystok | Podlaskie |
Lead Sponsor | Collaborator |
---|---|
Medical University of Bialystok |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 and 3 months | |
Primary | 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. | 1 and 3 months | |
Secondary | 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. | 1 and 3 months | |
Secondary | 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. | 1 and 3 months | |
Secondary | 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. | 1 and 3 months | |
Secondary | 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. | 1 and 3 months |
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