Investigating how genetics affect response to oral semaglutide in prediabetes and obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores the genetic factors influencing the response to a three-month treatment with oral semaglutide in individuals with prediabetes and obesity. Participants will undergo various assessments, including blood tests, glucose tolerance tests, and body composition analysis, to evaluate metabolic changes and hormonal responses. Additionally, genome-wide genotyping will be performed, and a subset of participants will have muscle and fat biopsies, along with MRI assessments of fat content in the liver, muscle, and pancreas. The goal is to understand how genetic variations impact treatment outcomes.

Why it matters

Who can join: the full rules

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's running

• Clinical Research Centre, Medical University of Bialystok
  Bialystok, Podlaskie Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Lukasz Szczerbinski, MD, PhD — Clinical Research Centre, Medical University of Bialystok
• Study coordinator: Lukasz Szczerbinski, MD, PhD
• Email: lukasz.szczerbinski@umb.edu.pl
• Phone: +48858318150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.