The Use of Glutamic Acid Decarboxylase (GAD) and Gamma-Amino Butyric Acid (GABA) in the Treatment of Type I Diabetes (GABA)
Type I Diabetes
About this trial
This is an interventional treatment trial for Type I Diabetes focused on measuring Diabetes
Eligibility 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.)
Sites / Locations
- Children's of Alabama
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Active Comparator
Active Comparator
Placebo GABA and Placebo GAD-alum
GABA and placebo GAD-alum
Active Oral GABA and Active GAD-alum Injection
Placebo formulation, Maltodextrin, for Gamma-Amino Butyric Acid (GABA) capsule-identical in appearance and taste, but no active medication will be taken with meals.Number of pills based on body surface area. Placebo GAD-alum(Glutamic Acid Decarboxylase in alum) injection- identical in appearance but no active medication will be received at baseline and 1 month.
Patients will receive the Active GABA (Gamma-Amino Butyric Acid) capsules. Each capsule 250mg. Dosage will be calculated according to body surface area of the child and divided between 2 meals/day. Larger dose taken with larger meal. Patients will receive the GAD-alum( Glutamic Acid Decarboxylase in alum) placebo at baseline and 1 month.
Patients will receive Oral GABA(Gamma-Amino Butyric Acid) 250mg capsules. Dosage (# of capsules) based on body surface area and divided between 2 meals/day. Patients will receive a primary (at baseline)injection of recombinant human GAD(Glutamic Acid Decarboxylase) in a standard vaccine formulation with alum, and a booster injection of the same at 1 month after baseline.