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

This study is currently recruiting participants.
Verified January 2013 by Huashan Hospital
Sponsor:
Information provided by (Responsible Party):
Zhaoyun Zhang, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT01781884
First received: January 12, 2013
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes
 Drug: Gamma Aminobutyric Acid (GABA)
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Huashan Hospital:

Primary Outcome Measures:
  • C-peptide value [ Time Frame: baseline and up to 52 weeks ] [ Designated as safety issue: No ]
    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 Measures:
  • HbA1C level [ Time Frame: baseline and up to 52 weeks ] [ Designated as safety issue: No ]
    The study will examine the HbA1C level every 3 months from baseline and up to 52 weeks.


Other Outcome Measures:
  • Daily dosage of insulin (units/kg). [ Time Frame: baseline and up to 52 weeks ] [ Designated as safety issue: No ]
    The study will assess the daily dosage of insulin (units/kg).


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gamma Aminobutyric Acid (GABA)
GABA will be given 50mg/kg/Day, thrice daily for 52 weeks
 Drug: Gamma Aminobutyric Acid (GABA)
two dosages will be used in this study. GABA: 50mg/kg/day and 100mg/kg/day
Other Name: Gamma Aminobutyric Acid
Active Comparator: Gamma Aminobutyric Acid GABA)
GABA will be given 100mg/kg/Day, thrice daily for 52 weeks.
 Drug: Gamma Aminobutyric Acid (GABA)
two dosages will be used in this study. GABA: 50mg/kg/day and 100mg/kg/day
Other Name: Gamma Aminobutyric Acid
Placebo Comparator: placebo
placebo will be given thrice daily for 52 weeks
 Drug: Placebo

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

  Eligibility

Ages Eligible for Study:   5 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781884

Locations
China, Shanghai
Department of Endocrinology and Metabolism，Huashan hospital Recruiting
Shanghai, Shanghai, China, 200040
Contact: Zhaoyun Zhang     86-21-52888286        
Contact: Yi Wang     86-21-52887022        
Principal Investigator: Yiming Li            
Principal Investigator: Qinghua Wang, Doctor            
Sponsors and Collaborators
Huashan Hospital
Investigators
Principal Investigator: Yiming Li, Doctor Huashan Hospital
Principal Investigator: Qinghua Wang, Doctor St Michale's Hospital, University of Toronto
  More Information

No publications provided

Responsible Party: Zhaoyun Zhang, clinical professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT01781884     History of Changes
Other Study ID Numbers: 2012-024
Study First Received: January 12, 2013
Last Updated: January 31, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Gamma-Aminobutyric Acid
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013