GABA Treatment in Subjects With Type 1 Diabetes
GABA Treatment in Subjects With Type 1 Diabetes
test if a food supplementation with GABA can improve insulin production capacity in type 1
 diabetes patients by turning alfa cells into beta cells in accordance with mice and cell
 studies.randomised parallel study with placebo as control
our results indicate that alfa-cells can be regenerated and used to regenerate functional
 beta-like cells in vivo in type 1 diabetes models. Aiming to eventually apply these findings
 to type 1 diabetic patients, we initiated multiple screens seeking for compounds inducing
 alfa-to-beta-cell conversion. Using the mouse as a model, we thereby found that GABA
 (gamma-aminobutyric acid) could promote a cycle of conversion of alfa-cells into functional
 beta-like cells,GABA being considered as a non-harmful food supplement, one could envision a
 trial in type 1 diabetic patients. Indeed, a putative cure for type 1 diabetes may include
 halting the autoimmune insult to the pancreatic beta-cells and restoring insulin secretion by
 expanding beta-cell mass by beta-cell-regeneration and/or preventing beta-cell apoptosis
 induced by cytokines. Immunosuppression initiated at the onset of type 1 diabetes has been
 shown to preserve beta-cell function, but is associated with significant toxicities. Other
 studies using nicotinamide and parenteral insulin have failed to prevent development of type
 1 diabetes.

 Objectives Primary objective: To investigate the effect and safety of the dietary supplement
 GABA provided at a dose of 6 g daily compared to placebo for 12 weeks on change in beta-cell
 function in patients with C-peptide negative type 1 diabetes as an adjunctive therapy to
 insulin treatment.

 Population A total of 30 patients with C-peptide negative type 1 diabetes, randomised 2:1
 GABA: Placebo.

 Intervention After randomisation patients are treated with the dietary supplement GABA or
 matching placebo, titrated to 3 x 2g, or maximum tolerated dose, for 12 weeks. The insulin
 dose is reduced if needed according to Self-monitored blood glucose (SMBG) and hypoglycaemic
 episodes.
Inclusion Criteria:stimulated c peptide <0.03 mmol/l type 1 diabetes

 -

 Exclusion Criteria:

 -  • Type 2 diabetes

 -  Fertile women not using chemical (tablet/pill, depot injection of progesterone,
 subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal
 patch) or mechanical (spirals) contraceptives

 -  Pregnant or nursing women

 -  Cancer unless in complete remission for > 5 years

 -  Treatment with oral glucocorticoids

 -  Hypoglycaemia unawareness (unability to register low blood glucose)

 -  Known or suspected hypersensitivity to trial product or related products

 -  Abuse of alcohol or drugs, or any other co-existing condition that would make
 patients unsuitable to participate in the study, as deemed by the investigators

 -  Receipt of an investigational drug within 30 days prior to visit 0

 -  Simultaneous participation in any other clinical intervention trial

 -  Chronic systemic use of steroids

 -  Seizure disorder

 -  Current use of Baclofen, Valium, Acamprosate, Neurontin, or Lyrica