For this trial, the investigators have recruited 101 children, aged 4–18 years, diagnosed with type 1 diabetes within the preceding 5 weeks and positive for the GAD65 antibody.
The participants have been randomly assigned to receive oral gamma aminobutyric acid (GABA), twice daily, with or without glutamic acid decarboxylase (GAD) in a standard vaccine formulation with alum given at baseline and 1 month, or matching placebos. The team will look at the effect on C-peptide concentrations at baseline and after 12 months of treatment.
GABA is synthesized from glutamate by GAD, and the research hypothesis is that it will promote beta-cell growth and survival, suppress inflammation, and increase T-regulatory cell numbers, thus delaying the progression of diabetes or even reversing it as shown in preclinical studies.
And the addition of recombinant GAD-alum injections aims to induce immune tolerance, thereby stopping the autoimmune response.
Results from this trial were presented at the 55th EASD Annual Meeting (EASD 2019):
Gamma Aminobutyric Acid (GABA): Role in pancreatic islet cell function and type 1 diabetes
Tuesday, September 17, 12:00–13:00. Vilanova Hall, Fira Barcelona Gran Via, Spain
Session Chair: K. McCormick, USA
- Effect of GABA on alpha and beta cell function and on the immune system in type 1 diabetes. Q. Wang, Canada
- Clinical trial presentation: Effect of gamma aminobutyric acid (GABA) or GABA with glutamic acid decarboxylase (GAD) on the progression of type 1 diabetes mellitus in children. K. McCormick, USA
What our Editorial Board said:
GABA has been shown in vitro to promote conversion of alpha cells to beta cells. Will GABA, given as a food supplement to people with C-Peptide negative type 1 diabetes, help restore beta-cell function?