Clinical trial

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

Recruiting now · Phase 4 · 1 countries · Registry ID NCT06003153

Recruiting nowPhase 4Interventional

What this study is about

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.

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

ConditionGenetic Predisposition, Metabolic Diseases, Type 2 Diabetes

Full registry criteria

Inclusion Criteria: 1. Males or non-pregnant females 2. Ages 18-65 (inclusive) 3. Able/willing to give consent 4. Span the metabolic range between normal glycemia and pre-diabetes (fasting glucose of 100-125 mg/dL based on chart review of existing laboratory data) Exclusion Criteria: 1. Currently taking medications or intending to take medications for diabetes 2. Currently taking medications or intending to take medications that affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones 3. Personal history of intestinal malabsorption, bariatric surgery, celiac disease, gallbladder disease, or pancreatitis 4. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 5. Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 per the Modification of Diet in Renal Disease equation 6. History of cirrhosis and/or aspartate aminotransferase or alanine aminotransferase more than 3x upper limit of normal 7. Dietary restrictions preventing consumption of a MMTT 8. Women who are pregnant, nursing, or at risk of becoming pregnant 9. Participation in other interventional studies during the current study

Treatments and study arms

oral semaglutide

Drug

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.

Mixed Meal Tolerance Test (MMTT)

Other

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.

Primary outcomes

Insulin response to oral semaglutide treatment15 days

Investigators will measure the change in insulin area under the curve (AUC) over 120 minutes of the MMTT, calculated using the trapezoidal method, between Visit 1 and Visit 2 as an index of response to oral semaglutide, and compare this outcome by genotype at selected loci.

Study locations

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

Massachusetts General Hospital🇺🇸 Boston, Massachusetts, United States

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Varinderpal KaurContact

Email · Call 6176435419

Josephine Li, MDPrincipal Investigator