Type 1 Diabetes Clinical Trial
Official title:
Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile
This study is a multicenter, randomized, double-masked, placebo-controlled clinical study.
All groups will receive standard intensive diabetes treatment with insulin and life style
management. 60 subjects will be randomly assigned in a 1:1:1 ratio to receive placebo or
different dosage of GABA.
GABA is an amino acid produced from glutamate by glutamic acid decarboxylase. It was
approved for the treatment of hepatic coma, fibromyalgia, ataxia in China and is widely used
as supplement for the treatment of epilepsy, insomnia, stress and tobacco dependence. It has
been recently shown that GABA can prevent and reverse the development of diabetes in type 1
mice models. Participants will receive placebo or GABA for 52 weeks.
The study will consist of 4 weeks screening period, 2 weeks run-in period, 52 weeks
treatment period and 4 weeks follow-up period. Enrollment is expected to occur over 2 years.
To assess the efficacy and safety of GABA for the treatment of juvenile type 1 diabetes in
new onset subjects.
Primary Outcome:
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.
Secondary Outcome:
The study will examine the HbA1C and the daily dosage of insulin (units/kg).
Exploratory Endpoint:
The study will assess the effects of treatment on inflammatory markers and immunological
outcomes.
Major Inclusion Criteria:
Type 1 diabetes within past 6 months Age 5-21 years* At least one diabetes associated
autoantibody
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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