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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01561508
Collaborator
(none)
0
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: gamma-amino-butyric acid
  • Dietary Supplement: Xylitol
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Jun 1, 2012
Anticipated Primary Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. change in stimulated c-peptide [over 1 year]

      We will measure c-peptide levels stimulated by a mixed meal tolerance test at baseline, six months and 12 months.

    Secondary Outcome Measures

    1. change in HbA1C [over 1 year]

      We will assess the change in hemoglobin A1C at baseline and every 3-4 months for a total duration of 1 year.

    2. change in total daily insulin dose per kilogram [over 1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Penny Jester, Principal Investigator, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT01561508
    Other Study ID Numbers:
    • UAB-GABA
    First Posted:
    Mar 23, 2012
    Last Update Posted:
    Dec 24, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by Penny Jester, Principal Investigator, University of Alabama at Birmingham
    diabetes mellitus
    children
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Butyric Acid

    Study Results

    No Results Posted as of Dec 24, 2012