Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children

This study has been withdrawn prior to enrollment.
(Unable to obtain IND currently)
Sponsor:
Information provided by (Responsible Party):
Penny Jester, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01561508
First received: March 16, 2012
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

Type 1 diabetes mellitus (T1DM) is an autoimmune disease in which the body's immune system attacks and destroys the insulin producing beta cells of the pancreas. This condition is very prevalent, affecting up to 1:400/500 persons worldwide. Type 1 diabetes, previously known as juvenile diabetes, usually strikes in childhood, adolescence, or young adulthood, but lasts for a lifetime. To date, there have been no treatments that can arrest or reverse the ongoing beta cell destruction. The patients affected by this disease require multiple daily insulin injections to manage their blood sugars and usually have trouble regulating their blood sugars. Moreover, they are at risk for heart disease, kidney failure, eye problems, and other complications from this life-long condition.

The investigators plan to utilize gamma-amino butyric acid (GABA) in children with newly diagnosed T1DM. This neurotransmitter is made in the brain from the amino acid glutamate with the aid of vitamin B6. There have been some recent studies in diabetic mice utilizing GABA to reverse inflammation on the pancreas and improve hyperglycemia. GABA studied in healthy human subjects demonstrated that large oral doses of GABA increased insulin secretion from the pancreas.

The investigators propose that GABA given to children with new onset T1DM will be able to increase insulin production, suppress glucagon release, and decrease the inflammation surrounding the pancreas. The investigators hope this will at least prolong the beta cell life after diagnosis, if not lead to a cure for type 1 diabetes.


Condition Intervention Phase
Diabetes Mellitus
Drug: gamma-amino-butyric acid
Dietary Supplement: Xylitol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blinded, Placebo Controlled Trial on the Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • change in stimulated c-peptide [ Time Frame: over 1 year ] [ Designated as safety issue: No ]
    We will measure c-peptide levels stimulated by a mixed meal tolerance test at baseline, six months and 12 months.


Secondary Outcome Measures:
  • change in HbA1C [ Time Frame: over 1 year ] [ Designated as safety issue: No ]
    We will assess the change in hemoglobin A1C at baseline and every 3-4 months for a total duration of 1 year.

  • change in total daily insulin dose per kilogram [ Time Frame: over 1 year ] [ Designated as safety issue: No ]
    We will assess the change in total daily insulin dose per kilogram of subject body weight at baseline and every 3-4 months for a total duration of 1 year.


Enrollment: 0
Study Start Date: June 2012
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GABA
2/3 of participants will be randomized to the GABA treatment group. Dosage will be based on body weight and will be adjusted at each study visit.
Drug: gamma-amino-butyric acid
gamma-amino butyric acid will be administered orally at a dose of 80mg/kg/day divided BID for one year.
Other Name: GABA
Placebo Comparator: Placebo
1/3 of participants will receive placebo.
Dietary Supplement: Xylitol
The placebo group will be provided Xylitol powder dosed per body weight. Participants will be instructed to take powder orally twice a day for one year.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive for any of the 3 measured antibodies GAD-65, ICA-512, or islet cell
  • Must meet the ADA criteria for diabetes diagnosis
  • Within 12 weeks of diagnosis of DMI at enrollment
  • Peak stimulated c peptide of > 0.2 ng/mL with Mixed Meal Tolerance Test
  • If post-menarchal they must use 2 forms of contraception during the study: this may include OCPs, abstinence and barrier methods. Abstinence will be accepted as a single method if used prior to enrollment.

Exclusion Criteria:

  • Chronic systemic use of steroids
  • Pregnancy or breastfeeding
  • Seizure disorder
  • Current use of Baclofen, Valium, Acamprosate, Neurontin, or Lyrica
  • History of alcoholism/alcohol use
  • Current use of anti diabetes drugs other than insulin
  • Diagnosis of hemoglobinopathy
  • Diagnosis of liver disease, cancer, cystic fibrosis, or renal failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561508

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Alison J Lunsford, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Penny Jester, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01561508     History of Changes
Other Study ID Numbers: UAB-GABA
Study First Received: March 16, 2012
Last Updated: December 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
diabetes mellitus
children

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

ClinicalTrials.gov processed this record on April 16, 2014