RecruitingPhase 4NCT06003153

GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH

Sponsor

Massachusetts General Hospital

Enrollment

125 participants

Start Date

Mar 12, 2024

Study Type

INTERVENTIONAL

Conditions

Genetic Predisposition Type 2 Diabetes Metabolic Diseases

Summary

The goal of this research study is to evaluate the pathophysiologic mechanisms by which genetic variation impacts response to an FDA-approved medication commonly used to treat type 2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological response to a mixed meal tolerance test (MMTT) before and after a 14-day treatment with oral semaglutide. The investigators will do this by measuring factors in the blood, such as sugars, fats, metabolites, and proteins, after eating a standardized breakfast meal at the first visit and after taking 14 doses of oral semaglutide over two weeks before the second study visit. The food (mixed meal breakfast) we will be studying is specially prepared to contain a set amount of protein, carbohydrates, and fat. The investigators hypothesize that understanding how the acute biochemical response to oral semaglutide differs by genetic variation will generate insight into drug mechanisms and type 2 diabetes pathophysiology.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing how an oral diabetes medication called semaglutide affects blood sugar and genes in people who are on the border between normal blood sugar and pre-diabetes. **You may be eligible if:** - You are between 18 and 50 years old - Your fasting blood sugar is in the pre-diabetes range (100–125 mg/dL) - You are male or a non-pregnant female **You may NOT be eligible if:** - You currently take or plan to take diabetes medications - You take steroids, growth hormone, or certain antibiotics (fluoroquinolones) that affect blood sugar - You have had bariatric surgery, celiac disease, gallbladder disease, or pancreatitis - You or a family member has had medullary thyroid cancer or a condition called multiple endocrine neoplasia type 2 - Your kidneys are not working well (low eGFR) - You have liver disease or significantly elevated liver enzymes - You are pregnant, nursing, or could become pregnant - You are currently in another interventional study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGoral semaglutide

Semaglutide is the only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) approved for treatment of type 2 diabetes. Participants will receive 7 mg of oral semaglutide once daily for 14 days in between Visit 1 and Visit 2.

OTHERMixed Meal Tolerance Test (MMTT)

The MMTT is developed by the Metabolism and Nutrition Metabolic Kitchen at the MGH TCRC. The meal is a high-calorie, high-carbohydrate and moderate-to-high glycemic index challenge composed of commonly consumed breakfast food items. It provides nearly 90 grams of carbohydrates and mimics an oral glucose challenge. The participants will undergo a MMTT at Visit 1 and Visit 2.