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

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.
 
ClinicalTrials.gov Identifier: NCT01561508
Recruitment Status : Withdrawn (Unable to obtain IND currently)
First Posted : March 23, 2012
Last Update Posted : December 24, 2012
Sponsor:
Information provided by (Responsible Party):
Penny Jester, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE March 16, 2012
First Posted Date  ICMJE March 23, 2012
Last Update Posted Date December 24, 2012
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
change in stimulated c-peptide [ Time Frame: over 1 year ]
We will measure c-peptide levels stimulated by a mixed meal tolerance test at baseline, six months and 12 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • change in HbA1C [ Time Frame: 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.
  • change in total daily insulin dose per kilogram [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children
Official Title  ICMJE Double Blinded, Placebo Controlled Trial on the Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: gamma-amino-butyric acid
  • Placebo Comparator: Placebo
    1/3 of participants will receive placebo.
    Intervention: Dietary Supplement: Xylitol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 21, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2012)
30
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01561508
Other Study ID Numbers  ICMJE UAB-GABA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Penny Jester, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alison J Lunsford, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP