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

NCT01781884 | Unknown DMC

• 1 other identifier: 2012-024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• HbA1C level

  baseline and up to 52 weeks

Other Outcomes (1)

• Daily dosage of insulin (units/kg).

  baseline and up to 52 weeks

Study Arms (3)

Gamma Aminobutyric Acid (GABA)

ACTIVE COMPARATOR

GABA will be given 50mg/kg/Day, thrice daily for 52 weeks

Drug: Gamma Aminobutyric Acid (GABA)

Gamma Aminobutyric Acid GABA)

ACTIVE COMPARATOR

GABA will be given 100mg/kg/Day, thrice daily for 52 weeks.

Drug: Gamma Aminobutyric Acid (GABA)

placebo

PLACEBO COMPARATOR

placebo will be given thrice daily for 52 weeks

Drug: Placebo

Interventions

Gamma Aminobutyric Acid (GABA) DRUG

two dosages will be used in this study. GABA: 50mg/kg/day and 100mg/kg/day

Also known as: Gamma Aminobutyric Acid

Gamma Aminobutyric Acid (GABA); Gamma Aminobutyric Acid GABA)

Placebo DRUG

placebo

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be between the ages of 5 and 21 years\*
• Be within 6-months of diagnosis of type 1 diabetes based on American Diabetes Association (ADA) criteria
• 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
• Presence of at least one diabetes-related autoantibody
• Must be willing to comply with intensive diabetes management and monitor glucose with glucometer.
• 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
• Parents and participants must sign the informed consent

You may not qualify if:

• Be currently pregnant or lactating or anticipate getting pregnant during the study period.
• Type 2 diabetes and other specific types of diabetes.
• Require use of systemic immunosuppressant, steroids or other medications that can affect glucose metabolism.
• Have a history of malignancies
• Be currently using non-insulin pharmaceuticals to affect glycemic control
• Have any acute or chronic complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
• Have a history of epilepsy, significant head trauma or cerebrovascular accident or clinical features of continuous motor unit activity in proximal muscles
• Inability or unwillingness to comply with the provisions of this protocol
• Have an active infection or positive PPD test result.
• Have serologic evidence of current or past HIV, Hep B, or Hep C infection.
• Be with acute complications of diabetes (diabetic ketoacidosis, nonketotic hypersmolar coma, diabetic lactic acidosis)
• Have a history of chronic renal failure, serum creatinine higher than 177umol/L
• Have a history of impaired liver function, ALT or AST level elevated more than (or equal to) 2.5 times of upper limmit normal.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Department of Endocrinology and Metabolism，Huashan hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

gamma-Aminobutyric Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Yiming Li, Doctor

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Qinghua Wang, Doctor

  St Michale's Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: January 12, 2013
• First Posted: February 1, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

CN (1)