Status:
RECRUITING
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Genetic Predisposition
Metabolic Diseases
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief 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 o...
Detailed Description
On day 1 (Visit 1), the research subject will present to the Translational and Clinical Research Center (TCRC) after an overnight fast. We will obtain informed consent, check vital signs, take anthrop...
Eligibility Criteria
Inclusion
- Males or non-pregnant females
- Ages 18-50 (inclusive)
- Able/willing to give consent
- 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
- Currently taking medications or intending to take medications for diabetes
- Currently taking medications or intending to take medications that affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
- Personal history of intestinal malabsorption, bariatric surgery, celiac disease, gallbladder disease, or pancreatitis
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
- Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 per the Modification of Diet in Renal Disease equation
- History of cirrhosis and/or aspartate aminotransferase or alanine aminotransferase more than 3x upper limit of normal
- Dietary restrictions preventing consumption of a MMTT
- Women who are pregnant, nursing, or at risk of becoming pregnant
- Participation in other interventional studies during the current study
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06003153
Start Date
March 12 2024
End Date
May 31 2027
Last Update
May 1 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114