NCT05340868 Genetics of the Acute Response to Oral Semaglutide
| NCT ID | NCT05340868 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Bialystok |
| Condition | PreDiabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2022-09-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) * 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
Contact & Investigator
Lukasz Szczerbinski, MD, PhD
PRINCIPAL INVESTIGATOR
Clinical Research Centre, Medical University of Bialystok
Frequently Asked Questions
Who can join the NCT05340868 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying PreDiabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05340868 currently recruiting?
Yes, NCT05340868 is actively recruiting participants. Contact the research team at lukasz.szczerbinski@umb.edu.pl for enrollment information.
Where is the NCT05340868 trial being conducted?
This trial is being conducted at Bialystok, Poland.
Who is sponsoring the NCT05340868 clinical trial?
NCT05340868 is sponsored by Medical University of Bialystok. The principal investigator is Lukasz Szczerbinski, MD, PhD at Clinical Research Centre, Medical University of Bialystok. The trial plans to enroll 1,000 participants.
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