Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children (GABA)
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.
|Diabetes Mellitus||Drug: gamma-amino-butyric acid Dietary Supplement: Xylitol||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double Blinded, Placebo Controlled Trial on the Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children|
- 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.
- 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.
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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.
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
Placebo Comparator: Placebo
1/3 of participants will receive placebo.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561508
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Alison J Lunsford, MD||University of Alabama at Birmingham|