Overview

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.)