| Trial ID: | L2916 |
| Source ID: | NCT01883804
|
| Associated Drug: |
Methyldopa
|
| Title: |
Effect of Methyldopa on MHC Class II Antigen Presentation in Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01883804/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Methyldopa
|
| Outcome Measures: |
Primary: The Change From Baseline of DQ8 Antigen Presentation by Peripheral Blood Mononuclear Cells After 6 Weeks of Methyldopa Treatment., Cryopreserved primary peripheral blood mononuclear cells were used as antigen presenting cells to stimulate engineered T-cells (T-cell receptor transductant) responding to a specific peptide presented by HLA-DQ8. Secreted IL-2 from the engineered T-cell was measured by a highly sensitive ELISA. This was done for both an α-gliadin/DQ8 responding T-cell and a separate insulin/DQ8 responding T-cell., 6 Weeks (Baseline and week 6) | Secondary: The Change in C-Peptide AUC Following a MMTT From Baseline to Study Completion., Investigators aim to observe changes in residual endogenous insulin production as measured by C-peptide 2 hour area under the curve following a Mixed Meal Tolerance Test (MMTT). C-peptide is a measure of endogenous insulin secretion as both are secreted in a 1:1 molar ratio. Individuals ingested a liquid meal (Boost) with a fixed amount of protein, fat and carbohydrate in the fasting state followed by the timed measurements of serum C-peptide at 0, 15, 30, 60, 90 and 120 minutes to compute the AUC., 12 weeks (Baseline and week 12)|The Change in Hemoglobin A1c From Baseline to Study Completion., Investigators aim to observe changes in hemoglobin A1c values, a measure of average blood glucose over the preceding 3 months., 12 weeks (Baseline and week 12)|The Change in Insulin Use From Baseline to Study Completion., Exogenous insulin use per kg of body weight., 12 weeks (Baseline and week 12)
|
| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver | Collaborators: Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-06
|
| Completion Date: |
2016-02
|
| Results First Posted: |
2018-03-29
|
| Last Update Posted: |
2022-01-18
|
| Locations: |
Barbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, Colorado, 80045, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01883804
|
