Genetics of the Acute Response to Oral Semaglutide
Recruiting · NCT05340868 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Clinical Research Centre, Medical University of Bialystok - Bialystok, Podlaskie Voivodeship, Poland