Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | April 2012 |
| Contact: | Jenni W Scholl, RN, BSN |
| Email: | jscholl@peds.uab.edu |
| Phone: | (205) 996-2134 |
Double Blinded, Placebo Controlled Trial on the Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children
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.
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
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