Diabetes MellitusPhase 2GABANCT01561508
Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children
A Phase 2 study testing gamma-amino-butyric acid and Xylitol in people with Diabetes Mellitus, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- gamma-amino-butyric acid and Xylitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Double Blinded, Placebo Controlled Trial on the Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children
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
- Being tested
- gamma-amino-butyric acid, Xylitol
- Keywords
- diabetes mellitus, children
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamma-amino-butyric acidDrug
Also called GABA
gamma-amino butyric acid will be administered orally at a dose of 80mg/kg/day divided BID for one year.
XylitolDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: gamma-amino-butyric acid |
| Placebo | Placebo comparator | 1/3 of participants will receive placebo. Receives: Dietary Supplement: Xylitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over 1 year
Secondary outcomes (2)
change in HbA1C
We will assess the change in hemoglobin A1C at baseline and every 3-4 months for a total duration of 1 year.
Measured: over 1 year
change in total daily insulin dose per kilogram
We will assess the change in total daily insulin dose per kilogram of subject body weight at baseline and every 3-4 months for a total duration of 1 year.
Measured: over 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2013 (estimated)
Why it stopped: Unable to obtain IND currently
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Penny Jester, University of Alabama at Birmingham
- Investigators
- Alison J Lunsford, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561508
- Sponsor's protocol ID
- UAB-GABA
- Acronym
- GABA
- Status last verified
- Dec 2012
- First submitted
- 16 Mar 2012
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded, Placebo Controlled Trial on the Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children
- ClinicalTrials.gov ID
- NCT01561508
- Acronym / sponsor ID
- GABA / UAB-GABA
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain IND currently
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (estimated)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GABA | Experimental | Drug: gamma-amino-butyric acid2/3 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. |
| Placebo | Placebo comparator | Dietary Supplement: Xylitol1/3 of participants will receive placebo. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Chronic systemic use of steroids
- Pregnancy or breastfeeding
- Seizure disorder
- Current use of Baclofen, Valium, Acamprosate, Neurontin, or Lyrica
- History of alcoholism/alcohol use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gamma-amino-butyric acidAlso: GABAgamma-amino butyric acid will be administered orally at a dose of 80mg/kg/day divided BID for one year. | Drug | GABA |
| XylitolThe 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. | Dietary supplement | Placebo |
Primary outcome
change in stimulated c-peptide
Time frame: over 1 year
We will measure c-peptide levels stimulated by a mixed meal tolerance test at baseline, six months and 12 months.
2 secondary outcomes
change in HbA1C
Time frame: over 1 year
change in total daily insulin dose per kilogram
Time frame: over 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison J Lunsford, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gamma-amino-butyric acid and Xylitol in people with Diabetes Mellitus, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in stimulated c-peptide (time frame: over 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2012.