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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01781884
• Other study ID #: 2012-024
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2013
• Last updated: January 31, 2013
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2013
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 21 Years

Eligibility

Inclusion Criteria:

1. Be between the ages of 5 and 21 years*

2. Be within 6-months of diagnosis of type 1 diabetes based on American Diabetes Association (ADA) criteria

3. Must have stimulated C-peptide levels =0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month of randomization

4. Presence of at least one diabetes-related autoantibody

5. Must be willing to comply with intensive diabetes management and monitor glucose with glucometer.

6. If participant is female with reproductive potential, she must be willing to avoid pregnancy during the whole study period and have a negative pregnancy test

7. Parents and participants must sign the informed consent

Exclusion Criteria:

1. Be currently pregnant or lactating or anticipate getting pregnant during the study period.

2. Type 2 diabetes and other specific types of diabetes.

3. Require use of systemic immunosuppressant, steroids or other medications that can affect glucose metabolism.

4. Have a history of malignancies

5. Be currently using non-insulin pharmaceuticals to affect glycemic control

6. Have any acute or chronic complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.

7. Have a history of epilepsy, significant head trauma or cerebrovascular accident or clinical features of continuous motor unit activity in proximal muscles

8. Inability or unwillingness to comply with the provisions of this protocol

9. Have an active infection or positive PPD test result.

10. Have serologic evidence of current or past HIV, Hep B, or Hep C infection.

11. Be with acute complications of diabetes (diabetic ketoacidosis, nonketotic hypersmolar coma, diabetic lactic acidosis)

12. Have a history of chronic renal failure, serum creatinine higher than 177umol/L

13. Have a history of impaired liver function, ALT or AST level elevated more than (or equal to) 2.5 times of upper limmit normal.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
China	Department of Endocrinology and Metabolism,Huashan hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Daily dosage of insulin (units/kg).	The study will assess the daily dosage of insulin (units/kg).	baseline and up to 52 weeks	No
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	No
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	No