GABA Treatment in Subjects With Type 1 Diabetes

NCT ID: NCT03721991

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2019-07-01

Brief Summary

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

Detailed 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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

GABA

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

Group Type: ACTIVE_COMPARATOR

Gama amino butyric acid (GABA)

Intervention Type: DIETARY_SUPPLEMENT

food supplement Gama amino butyric acid (GABA) as capsules

PLACEBO

Matching placebo capsules to GABA

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

matching placebo

Interventions

Gama amino butyric acid (GABA)

food supplement Gama amino butyric acid (GABA) as capsules

Intervention Type: DIETARY_SUPPLEMENT

placebo

matching placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

gaba

Eligibility Criteria

Inclusion Criteria

-

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

peter Rossing, md

Role: STUDY_CHAIR

Steno Diabetes Center Copenhagen

Locations

Steno Diabetes Center Copenhagen

Gentofte Municipality, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Peter Rossing, MD

Role: CONTACT

peter.rossing@regionh.dk

004530913383

Facility Contacts

Peter Rossing, MD

Role: primary

peter.rossing@regionh.dk

Other Identifiers

H17041847

Identifier Type: -

Identifier Source: org_study_id