Clinical trial

Genetics of the Acute Response to Oral Semaglutide

Recruiting now · Not applicable · 1 countries · Registry ID NCT05340868

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionPreDiabetes, Prediabetic State, Obesity

Full registry 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

Treatments and study arms

Semaglutide Pill

Drug

Oral semaglutide treatment

Primary outcomes

Glycemic measures - change in HbA1c (%)1 and 3 months

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.

Body composition - change in body weight (kg)1 and 3 months

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Clinical Research Centre, Medical University of Bialystok🇵🇱 Bialystok, Podlaskie Voivodeship, Poland

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Lukasz Szczerbinski, MD, PhDContact

Email · Call +48 85 831 81 50

Adam Kretowski, MD, PhDPrincipal Investigator

Lukasz Szczerbinski, MD, PhDPrincipal Investigator