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

The University of Alabama at Birmingham

Status and phase: Withdrawn; Phase 2

Conditions: Diabetes Mellitus

Treatments: Dietary Supplement: Xylitol; Drug: gamma-amino-butyric acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01561508

UAB-GABA

Details and patient eligibility

About

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.

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

GABA

Experimental group

Description:

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.

Treatment:

Drug: gamma-amino-butyric acid

Placebo

Placebo Comparator group

Description:

1/3 of participants will receive placebo.

Treatment:

Dietary Supplement: Xylitol