NCT01781884

Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile Type 1 Diabetes

Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Gamma Aminobutyric Acid (GABA)	two dosages will be used in this study. GABA: 50mg/kg/day and 100mg/kg/day
DRUG	Placebo

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-02-01
• Last updated: 2013-02-01

Locations

1 site across 1 country: China