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

NCT ID: NCT01561508

Last Updated: 2012-12-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30

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.

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus; children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

gamma-amino-butyric acid

Intervention Type: DRUG

gamma-amino butyric acid will be administered orally at a dose of 80mg/kg/day divided BID for one year.

Placebo

1/3 of participants will receive placebo.

Group Type: PLACEBO_COMPARATOR

Xylitol

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

gamma-amino-butyric acid

gamma-amino butyric acid will be administered orally at a dose of 80mg/kg/day divided BID for one year.

Intervention Type: DRUG

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

GABA

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Penny Jester

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alison J Lunsford, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB-GABA

Identifier Type: -

Identifier Source: org_study_id