| Trial ID: | L4747 |
| Source ID: | NCT02913703
|
| Associated Drug: |
Ghrelin
|
| Title: |
Preprandial Ghrelin Effect
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Ghrelin|OTHER: Saline
|
| Outcome Measures: |
Primary: Effect of preprandial ghrelin on glucose tolerance, Primary Outcome: Glucose area under the curve during 60-minute Meal Tolerance test in healthy subjects and in Type 2 diabetic subjects, Approximately 4-8 weeks | Secondary: Effect of preprandial ghrelin on GLP-1 secretion, Secondary Outcome: Effect of preprandial ghrelin on GLP-1 area under the curve during a mixed meal in healthy subjects and in Type 2 diabetic subjects, Approx 4-8 weeks|Effect of preprandial ghrelin on insulin secretion, Secondary Outcome: Effect of preprandial ghrelin on insulin and c-peptide area under the curve during a mixed meal in healthy subjects and in Type 2 diabetic subjects, Approx 4-8 weeks|Effect of preprandial ghrelin on beta cell function, Secondary Outcome: Effect of preprandial ghrelin on beta cell function (as measured by Disposition Index = \[ (Area under the insulin curve / Area under the glucose curve) X Matsuda Index\] during a 60-minute Meal Tolerance test in healthy subjects and in Type 2 diabetic subjects, Approx 4-8 weeks|Effect of preprandial ghrelin on insulin sensitivity (as measured by Matsuda index), Approx 4-8 weeks
|
| Sponsor/Collaborators: |
Sponsor: Jenny Tong, MD, MPH | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
80
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2017-01-11
|
| Completion Date: |
2018-12
|
| Results First Posted: |
|
| Last Update Posted: |
2019-03-12
|
| Locations: |
Duke Center For Living, Durham, North Carolina, 27705, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02913703
|
