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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 10 September 2018
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: Active, not recruiting
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:   Sharon D. May, BSN
Address: 
Telephone: 205-638-5031
Email: smay@peds.uab.edu
Affiliation: 
Name:   Sharon D May, BSN
Address: 
Telephone: 205-996-2134
Email: smay@peds.uab.edu
Affiliation: 
Name:   Kenneth McCormick, MD
Address: 
Telephone:
Email:
Affiliation:  Division Director Pediatric Endocrinology
Name:   Heather Choat, MD
Address: 
Telephone:
Email:
Affiliation:  Pediatric Endocrinology
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: Gamma-Aminobutyric Acid
Drug: Glutamic Acid Decarboxylase in alum formulation
Drug: Maltodextrin
Drug: Placebo GAD-alum
Primary Outcome(s)
Compare the effect of oral GABA or oral GABA/GAD combination administration on pancreatic beta cell function by peptide secretion [Time Frame: 12 months after baseline]
Compare the effect of oral GABA or oral GABA/GAD combination administration on pancreatic beta cell function by use of insulin [Time Frame: 12 months after baseline]
Secondary Outcome(s)
Compare the effect of oral GABA or GABA/GAD administration on diabetes autoantibodies GAD-65 [Time Frame: 12 months after baseline]
Compare the effect of oral GABA or GABA/GAD administration on diabetes autoantibodies IA2 [Time Frame: 12 months after baseline]
Compare the effect of oral GABA or GABA/GAD administration on diabetes autoantibodies ICA [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)
Diamyd Inc
Janssen Pharmaceuticals
Juvenile Diabetes Research Foundation
NOW Foods
Results
Results available:
Date Posted:
URL:
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