Actively Recruiting
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
Led by Massachusetts General Hospital · Updated on 2026-04-06
125
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how genetic differences affect the body's response to oral semaglutide, a medication approved by the FDA for treating type 2 diabetes. This study aims to better understand the biological effects of the drug and how the body reacts to a mixed meal before and after treatment. By measuring changes in blood sugars, fats, metabolites, and proteins, the study hopes to provide new insights into type 2 diabetes and drug response. Participants will undergo a mixed meal tolerance test (MMTT) on the first day after fasting overnight. They will then take 7 mg of oral semaglutide once daily for 14 days. On the 16th day, participants return to take their final dose and repeat the mixed meal test with blood samples taken at multiple time points to assess the body's response while on the medication. During the study, participants will have vital signs checked, fasting blood samples collected, and anthropometric measurements taken. Blood will be drawn multiple times after consuming the standardized mixed meal at two visits. The primary outcome measured is the insulin response after 15 days of oral semaglutide treatment. Other outcomes include glucose levels and hormone responses. The total participation time spans about 16 days.
CONDITIONS
Brief Title
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or non-pregnant females
- Ages 18 to 65 years (inclusive)
- Able and willing to give informed consent
- Fasting glucose between 100 and 125 mg/dL indicating normal to pre-diabetes range based on existing lab data
You will not qualify if you...
- Currently taking or planning to take medications for diabetes
- Taking or planning to take medications affecting blood sugar such as glucocorticoids, growth hormone, or fluoroquinolones
- 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) below 60 ml/min/1.73 m2
- History of cirrhosis or liver enzyme levels more than three times normal
- Dietary restrictions preventing consumption of the mixed meal tolerance test
- Women who are pregnant, nursing, or at risk of becoming pregnant
- Participation in other interventional studies during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 days
Participants take 7 mg of oral semaglutide once daily for 14 days. They also complete mixed meal tolerance tests before starting and after completing the treatment to measure blood responses.
2 visits (in-person) on Day 1 and Day 16, plus daily oral medication at home from Day 3 to Day 15
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
V
Varinderpal Kaur
J
Josephine Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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