| Trial ID: | L7265 |
| Source ID: | NCT06003153
|
| Associated Drug: |
Oral Semaglutide
|
| Title: |
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
|
| Acronym: |
GLUCOSE-MGH
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Genetic Predisposition|Metabolic Diseases|Type 2 Diabetes
|
| Interventions: |
DRUG: oral semaglutide|OTHER: Mixed Meal Tolerance Test (MMTT)
|
| Outcome Measures: |
Primary: Insulin response to oral semaglutide treatment, 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., 15 days | Secondary: Fasting glucose response to oral semaglutide treatment, Investigators will measure the change in fasting glucose over 120 minutes of the MMTT, between the two visits, and compare this outcome by genotype at selected loci., 15 days|Cumulative glucose response to oral semaglutide treatment, Investigators will measure the change in glucose area under the curve (AUC) over 120 minutes of the MMTT, between the two visits, and compare this outcome by genotype at selected loci., 15 days|Baseline incretin level, Investigators will measure levels of GLP-1 during the length of the baseline MMTT (120 minutes) that takes place on Visit 1, and compare changes in the baseline levels by genotype at selected loci., 120 minutes during Visit 1
|
| Sponsor/Collaborators: |
Sponsor: Massachusetts General Hospital | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
125
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-03-12
|
| Completion Date: |
2027-05-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-04-17
|
| Locations: |
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06003153
|
