| Trial ID: | L5124 |
| Source ID: | NCT01781884
|
| Associated Drug: |
Gamma Aminobutyric Acid (Gaba)
|
| Title: |
Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile Type 1 Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Gamma Aminobutyric Acid (GABA)|DRUG: Placebo
|
| Outcome Measures: |
Primary: C-peptide value, The primary statistical hypothesis to be assessed in this study is whether the mean C-peptide value for study subjects receiving GABA differs significantly from the mean value for placebo subjects assessed at follow-up., baseline and up to 52 weeks | Secondary: HbA1C level, The study will examine the HbA1C level every 3 months from baseline and up to 52 weeks., baseline and up to 52 weeks | Other: Daily dosage of insulin (units/kg)., The study will assess the daily dosage of insulin (units/kg)., baseline and up to 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Huashan Hospital
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-01
|
| Completion Date: |
2014-12
|
| Results First Posted: |
|
| Last Update Posted: |
2013-02-01
|
| Locations: |
Department of Endocrinology and Metabolism，Huashan hospital, Shanghai, Shanghai, 200040, China
|
| URL: |
https://clinicaltrials.gov/show/NCT01781884
|
