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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Zhaoyun Zhang, Huashan Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781884
First Posted: February 1, 2013
Last Update Posted: February 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhaoyun Zhang, Huashan Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile

Resource links provided by NLM:


Further study details as provided by Zhaoyun Zhang, Huashan Hospital:

Primary Outcome Measures:
  • C-peptide value [ Time Frame: baseline and up to 52 weeks ]
    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 ]
    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 ]
    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

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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Zhaoyun Zhang, clinical professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT01781884     History of Changes
Other Study ID Numbers: 2012-024
First Submitted: January 12, 2013
First Posted: February 1, 2013
Last Update Posted: February 4, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
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
Physiological Effects of Drugs