The Use of Glutamic Acid Decarboxylase (GAD) and Gamma-Amino Butyric Acid (GABA) in the Treatment of Type I Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 16 May 2022
• Main ID: NCT02002130
• Date of registration: 18/11/2013
• Prospective Registration: Yes
• Primary sponsor: University of Alabama at Birmingham
• Public title: The Use of Glutamic Acid Decarboxylase (GAD) and Gamma-Amino Butyric Acid (GABA) in the Treatment of Type I Diabetes GABA
• Scientific title: The Use of Glutamic Acid Decarboxylase (GAD)and Gamma-Amino Butyric Acid(GABA)in the Treatment of Type I Diabetes.
• Date of first enrolment: January 2015
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02002130
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Gail Mick, MD
• Affiliation: University of Alabama at Birmingham

• Name: Kenneth McCormick, MD
• Affiliation: University of Alabama at Birmingham

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must be positive for GAD-65 antibody.

- They must meet ADA criteria for diabetes: classic symptoms, plus blood sugar >
200mg/dL or fasting blood sugar > 126 mg/dL.

- Must be enrolled with 5 weeks of diagnosis

- Females who are post-menarchal must use 2 forms of contraception if not abstinent. The
types of contraception deemed acceptable would be oral contraceptives, intrauterine
devices, and barrier methods.

- Signed informed consent form.

Exclusion Criteria:

- Chronic systemic steroid use, including inhaled compounds, or any medication which can
alter glucose metabolism

- Obesity, defined as BMI > 95% or BMI > 27 in adolescents with acanthosis score between
1-1.5.

- Pregnant and/or breast feeding

- History of seizure disorder

- Patients on medications that may disturb GABA action, such as Baclofen, Valium,
Acamprosate, Neurontin, or Lyrica

- history of any alcoholism or substance abuse.

- Chronic Disease (such as liver, cancer, cystic fibrosis, or renal failure)

- Chromosome abnormality (such as Trisomy 21, Turner Syndrome, etc.)



Age minimum: 4 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type I Diabetes

Intervention(s)

Drug: Active Oral GABA and Active GAD-alum injection

Drug: GABA and Placebo GAD-alum

Drug: Placebo GABA and Placebo GAD-alum

Primary Outcome(s)

Compare the effect of oral GABA or oral GABA/GAD combination administration on pancreatic beta cell function by quantitative C-peptide secretion [Time Frame: 12 months after baseline]

Secondary Outcome(s)

Compare the effect of oral GABA or GABA/GAD administration on total daily insulin usage by participants and corrected Hemoglobin A1C. [Time Frame: 12 months after baseline]

Compare the effect of oral GABA or oral GABA/GAD administration on diabetes related autoantibodies [Time Frame: 12 months after baseline]

Compare the effect of oral GABA or GABA/GAD administration on fasting and meal stimulated glucagon and pro-insulin levels. [Time Frame: 12 months after baseline]

Compare the effect of oral GABA or oral GABA/GAD administration on indices of immune system function. [Time Frame: 12 months after baseline]

Secondary ID(s)

GABA-GAD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

NOW Foods

Janssen Pharmaceuticals

Diamyd Inc

Juvenile Diabetes Research Foundation