Clinical Trial Details

NCT ID: NCT02002130
Date Last Changed: October 31, 2016

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Maltodextrin, Placebo GAD-alum, Glutamic Acid Decarboxylase (GAD) in alum formulation and Gamma-Aminobutyric Butyric Acid (GABA) for the treatment of Type I Diabetes

Research Study Title

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

Purpose

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.

To Learn more

Recruitment Details

Phase
1
Gender
All
Age
4 to 18 Years
Overall Status
Recruiting
Lead Sponsor
University of Alabama at Birmingham
Duration
53 Months
Facility Type
N/A
Compensation

Eligibility

All ages 4 Years to 18 Years

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.)

Site Locations (1)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35233 Children's of Alabama
Sharon D. May, BSN
205-996-2134
smay@peds.uab.edu

Kenneth McCormick, MD
Sub-Investigator

Alexandra Martin, MD
Principal Investigator

Gail Mick, MD
Sub-Investigator

Ambika Ashraf, MD
Sub-Investigator

Atchison Joycelyn, MD
Sub-Investigator

Contact

Sharon D May, BSN
205-996-2134
E-mail:

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