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

Diabetes Mellitus Clinical Trial

— GABA  

Official title:

Double Blinded, Placebo Controlled Trial on the Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01561508
• Other study ID #: UAB-GABA
• Status: Withdrawn
• Phase: Phase 2
• First received: March 16, 2012
• Last updated: December 21, 2012
• Start date: June 2012

Study information

• Verified date: December 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in stimulated c-peptide	We will measure c-peptide levels stimulated by a mixed meal tolerance test at baseline, six months and 12 months.	over 1 year	No
Secondary	change in HbA1C	We will assess the change in hemoglobin A1C at baseline and every 3-4 months for a total duration of 1 year.	over 1 year	No
Secondary	change in total daily insulin dose per kilogram	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.	over 1 year	No