Understanding genetic effects on response to oral semaglutide in type 2 diabetes

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 research evaluates how genetic variations influence the response to oral semaglutide, a medication for type 2 diabetes. Participants will undergo a mixed meal tolerance test before and after a 14-day treatment with oral semaglutide, allowing researchers to measure changes in blood factors such as sugars, fats, and proteins. The study aims to uncover the biochemical mechanisms behind the drug's effectiveness and its relationship to type 2 diabetes pathophysiology.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Josephine Li, MD — Mgh
• Study coordinator: Varinderpal Kaur
• Email: vkaur@mgh.harvard.edu
• Phone: 6176435419

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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.