| Trial ID: | L6444 |
| Source ID: | NCT02440061
|
| Associated Drug: |
Synthetic Human Ag
|
| Title: |
Ghrelin and Beta Cell Function in Diabetes
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Synthetic human AG|DRUG: Arginine|DRUG: 0.9% saline solution
|
| Outcome Measures: |
Primary: Postprandial insulin secretion (ISR-meal), Postprandial insulin secretion (ISR-meal) will be derived from plasma C-peptide concentrations during MTT (0-240 min) using deconvolution with population estimates of C-peptide clearance., approximately 8 weeks|Index of β-cell sensitivity to glucose, Index of β-cell sensitivity to glucose will be calculated as incremental insulin/glucose (I/G) AUC (ΔAUCI/G)., approximately 8 weeks|Whole body insulin sensitivity using the Matsuda Index, The Matsuda Index is a well-known index of insulin sensitivity derived from several glucose and insulin values obtained during a mixed meal, approximately 8 weeks|β-cell function (DI-meal), β-cell function (DI-meal) will be calculated as ΔAUCI/G x Matsuda Index, approximately 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: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2018-05
|
| Completion Date: |
2019-06
|
| Results First Posted: |
|
| Last Update Posted: |
2018-04-02
|
| Locations: |
Duke Center For Living, Durham, North Carolina, 27705, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02440061
|
