GABA Treatment in Subjects With Type 1 Diabetes (GABA-1)

Steno Diabetes Centers

Status: Unknown

Conditions: Type 1 Diabetes Mellitus

Treatments: Dietary Supplement: placebo; Dietary Supplement: Gama amino butyric acid (GABA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03721991

H17041847

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

GABA

Active Comparator group

Description:

gamma Amino butyric acid (GABA) food supplement with 6 g per day

Treatment:

Dietary Supplement: Gama amino butyric acid (GABA)

PLACEBO

Placebo Comparator group

Description:

Matching placebo capsules to GABA

Treatment:

Dietary Supplement: placebo