Status:
RECRUITING
Genetics of the Acute Response to Oral Semaglutide
Lead Sponsor:
Medical University of Bialystok
Conditions:
PreDiabetes
Prediabetic State
Eligibility:
All Genders
18-65 years
Phase:
NA
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 r...
Detailed Description
Each subject will participate in the following visits: Visit v1 (screening) - for each patient, fasting venous blood will be collected and an oral glucose tolerance test (OGTT) will be performed - wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05340868
Start Date
September 1 2022
End Date
December 31 2025
Last Update
March 26 2025
Active Locations (1)
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1
Clinical Research Centre, Medical University of Bialystok
Bialystok, Podlaskie Voivodeship, Poland, 15-276