| Trial ID: | L2374 |
| Source ID: | NCT02002130
|
| Associated Drug: |
Placebo Gaba And Placebo Gad-Alum
|
| Title: |
The Use of Glutamic Acid Decarboxylase (GAD) and Gamma-Amino Butyric Acid (GABA) in the Treatment of Type I Diabetes
|
| Acronym: |
GABA
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type I Diabetes
|
| Interventions: |
DRUG: Placebo GABA and Placebo GAD-alum|DRUG: GABA and Placebo GAD-alum|DRUG: Active Oral GABA and Active GAD-alum injection
|
| Outcome Measures: |
Primary: Compare the effect of oral GABA or oral GABA/GAD combination administration on pancreatic beta cell function by quantitative C-peptide secretion, This will be assessed by meal stimulated c-peptide secretion in treatment cohorts compared to age matched placebo controls before and after 1 year of treatment., 12 months after baseline | Secondary: Compare the effect of oral GABA or GABA/GAD administration on fasting and meal stimulated glucagon and pro-insulin levels., This will be assessed by meal stimulated glucagon and pro-insulin secretion in treatment cohorts compared with age matched placebo controls before and after 1 year of treatment., 12 months after baseline|Compare the effect of oral GABA or GABA/GAD administration on total daily insulin usage by participants and corrected Hemoglobin A1C., This will be assessed by measuring insulin usage and corrected Hemoglobin A1C linearly for each participant, in addition to comparison with age matched controls, 12 months after baseline|Compare the effect of oral GABA or oral GABA/GAD administration on indices of immune system function., This will be assessed by measuring immunologic markers of inflammation linearly over the 12 month treatment course for each patient and comparing to age matched placebo controls., 12 months after baseline|Compare the effect of oral GABA or oral GABA/GAD administration on diabetes related autoantibodies, This will be assessed by measuring GAD65, ICA512, and Zinc Transporter 8 antibodies throughout the treatment period., 12 months after baseline
|
| Sponsor/Collaborators: |
Sponsor: University of Alabama at Birmingham | Collaborators: Diamyd Inc|NOW Foods|Janssen Pharmaceuticals|Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
101
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-01
|
| Completion Date: |
2022-04-15
|
| Results First Posted: |
|
| Last Update Posted: |
2022-05-06
|
| Locations: |
Children's of Alabama, Birmingham, Alabama, 35233, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02002130
|
