Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children

NCT01561508 | Withdrawn Phase 2

• 1 other identifier: UAB-GABA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 diabetes mellitus (T1DM) is an autoimmune disease in which the body's immune system attacks and destroys the insulin producing beta cells of the pancreas. This condition is very prevalent, affecting up to 1:400/500 persons worldwide. Type 1 diabetes, previously known as juvenile diabetes, usually strikes in childhood, adolescence, or young adulthood, but lasts for a lifetime. To date, there have been no treatments that can arrest or reverse the ongoing beta cell destruction. The patients affected by this disease require multiple daily insulin injections to manage their blood sugars and usually have trouble regulating their blood sugars. Moreover, they are at risk for heart disease, kidney failure, eye problems, and other complications from this life-long condition. The investigators plan to utilize gamma-amino butyric acid (GABA) in children with newly diagnosed T1DM. This neurotransmitter is made in the brain from the amino acid glutamate with the aid of vitamin B6. There have been some recent studies in diabetic mice utilizing GABA to reverse inflammation on the pancreas and improve hyperglycemia. GABA studied in healthy human subjects demonstrated that large oral doses of GABA increased insulin secretion from the pancreas. The investigators propose that GABA given to children with new onset T1DM will be able to increase insulin production, suppress glucagon release, and decrease the inflammation surrounding the pancreas. The investigators hope this will at least prolong the beta cell life after diagnosis, if not lead to a cure for type 1 diabetes.

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus; children

Outcome Measures

Primary Outcomes (1)

• change in stimulated c-peptide

  We will measure c-peptide levels stimulated by a mixed meal tolerance test at baseline, six months and 12 months.

  over 1 year

Secondary Outcomes (2)

• change in HbA1C

  over 1 year

• change in total daily insulin dose per kilogram

  over 1 year

Study Arms (2)

GABA

EXPERIMENTAL

2/3 of participants will be randomized to the GABA treatment group. Dosage will be based on body weight and will be adjusted at each study visit.

Drug: gamma-amino-butyric acid

Placebo

PLACEBO COMPARATOR

1/3 of participants will receive placebo.

Dietary Supplement: Xylitol

Interventions

gamma-amino-butyric acid DRUG

gamma-amino butyric acid will be administered orally at a dose of 80mg/kg/day divided BID for one year.

Also known as: GABA

GABA

Xylitol DIETARY_SUPPLEMENT

The placebo group will be provided Xylitol powder dosed per body weight. Participants will be instructed to take powder orally twice a day for one year.

Placebo

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Positive for any of the 3 measured antibodies GAD-65, ICA-512, or islet cell
• Must meet the ADA criteria for diabetes diagnosis
• Within 12 weeks of diagnosis of DMI at enrollment
• Peak stimulated c peptide of \> 0.2 ng/mL with Mixed Meal Tolerance Test
• If post-menarchal they must use 2 forms of contraception during the study: this may include OCPs, abstinence and barrier methods. Abstinence will be accepted as a single method if used prior to enrollment.

You may not qualify if:

• Chronic systemic use of steroids
• Pregnancy or breastfeeding
• Seizure disorder
• Current use of Baclofen, Valium, Acamprosate, Neurontin, or Lyrica
• History of alcoholism/alcohol use
• Current use of anti diabetes drugs other than insulin
• Diagnosis of hemoglobinopathy
• Diagnosis of liver disease, cancer, cystic fibrosis, or renal failure

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

gamma-Aminobutyric Acid; Xylitol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Sugar Alcohols; Alcohols; Carbohydrates

Study Officials

• Alison J Lunsford, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 23, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2013
• Last Updated: December 24, 2012

Record last verified: 2012-12

Locations

US (1)