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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Type I Diabetes is an auto immune disease in which the body's immune system attacks and destroys the insulin-producing beta cells of the pancreas. Therefore, children affected by this condition present with high blood sugars. This condition affects 1:400/500 persons worldwide.Type I Diabetes, previously known as Juvenile Diabetes,usually strikes in childhood, adolescence, or young adulthood, but lasts for a lifetime. To date, there has been no treatments that can arrest, or reverse the ongoing beta cell destruction. We hypothesize that GABA, a naturally occurring substance, has the potential to reduce the inflammation and protect the pancreatic beta cells from autoimmune destruction. GAD-alum may contribute to the preservation of residual insulin secretion in patients with recent onset, Type I Diabetes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborators: Diamyd Inc; Janssen Pharmaceuticals; Juvenile Diabetes Research Foundation; NOW Foods
• Treatments: Aluminum sulfate; Butyric Acid; gamma-Aminobutyric Acid

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.)