Understanding genetic effects on response to oral semaglutide in type 2 diabetes
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
PHASE4 · Massachusetts General Hospital · NCT06003153
This study is testing how different genes affect how well people with type 2 diabetes respond to the oral medication semaglutide.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06003153 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males or non-pregnant females aged 18-50 with normal glycemia to pre-diabetes.
Not a fit: Patients currently on diabetes medications or those with certain medical histories, such as intestinal malabsorption or pancreatitis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for individuals with type 2 diabetes based on their genetic profiles.
How similar studies have performed: Other studies have shown promise in understanding genetic influences on drug responses, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Genetic Predisposition, Metabolic Diseases, Type 2 Diabetes