Genetics of the Acute Response to Oral Semaglutide

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

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

Conditions4

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