Type 1 DiabetesNCT01781884
Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile Type 1 Diabetes
A study testing Gamma Aminobutyric Acid (GABA) in people with Type 1 Diabetes, run by Huashan Hospital at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-masked, placebo-controlled clinical study. All groups will receive standard intensive diabetes treatment with insulin and life style management. 60 subjects will be randomly assigned in a 1:1:1 ratio to receive placebo or different dosage of GABA. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Gamma Aminobutyric Acid (GABA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- 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 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be between the ages of 5 and 21 years*
- Be within 6-months of diagnosis of type 1 diabetes based on American Diabetes Association (ADA) criteria
- Must have stimulated C-peptide levels ≥0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month of randomization
- Presence of at least one diabetes-related autoantibody
- Must be willing to comply with intensive diabetes management and monitor glucose with glucometer.
- If participant is female with reproductive potential, she must be willing to avoid pregnancy during the whole study period and have a negative pregnancy test
- Parents and participants must sign the informed consent
Who cannot join
- Be currently pregnant or lactating or anticipate getting pregnant during the study period.
- Type 2 diabetes and other specific types of diabetes.
- Require use of systemic immunosuppressant, steroids or other medications that can affect glucose metabolism.
- Have a history of malignancies
- Be currently using non-insulin pharmaceuticals to affect glycemic control
- Have any acute or chronic complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
Show all 13Show fewer
- Have a history of epilepsy, significant head trauma or cerebrovascular accident or clinical features of continuous motor unit activity in proximal muscles
- Inability or unwillingness to comply with the provisions of this protocol
- Have an active infection or positive PPD test result.
- Have serologic evidence of current or past HIV, Hep B, or Hep C infection.
- Be with acute complications of diabetes (diabetic ketoacidosis, nonketotic hypersmolar coma, diabetic lactic acidosis)
- Have a history of chronic renal failure, serum creatinine higher than 177umol/L
- Have a history of impaired liver function, ALT or AST level elevated more than (or equal to) 2.5 times of upper limmit normal.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Metabolism，Huashan hospital
Shanghai, Shanghai Municipality, 200040
Zhaoyun Zhang, 86-21-52888286
Yi Wang, 86-21-52887022
About this study
Official title: Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile
This study is a multicenter, randomized, double-masked, placebo-controlled clinical study. All groups will receive standard intensive diabetes treatment with insulin and life style management. 60 subjects will be randomly assigned in a 1:1:1 ratio to receive placebo or different dosage of GABA.
GABA is an amino acid produced from glutamate by glutamic acid decarboxylase. It was approved for the treatment of hepatic coma, fibromyalgia, ataxia in China and is widely used as supplement for the treatment of epilepsy, insomnia, stress and tobacco dependence. It has been recently shown that GABA can prevent and reverse the development of diabetes in type 1 mice models. Participants will receive placebo or GABA for 52 weeks.
Read more
The study will consist of 4 weeks screening period, 2 weeks run-in period, 52 weeks treatment period and 4 weeks follow-up period. Enrollment is expected to occur over 2 years.
To assess the efficacy and safety of GABA for the treatment of juvenile type 1 diabetes in new onset subjects.
Read the detailed description
Primary Outcome:
The primary statistical hypothesis to be assessed in this study is whether the mean C-peptide value for study subjects receiving GABA differs significantly from the mean value for placebo subjects assessed at follow-up.
Secondary Outcome:
The study will examine the HbA1C and the daily dosage of insulin (units/kg).
Exploratory Endpoint:
The study will assess the effects of treatment on inflammatory markers and immunological outcomes.
Major Inclusion Criteria:
Type 1 diabetes within past 6 months Age 5-21 years* At least one diabetes associated autoantibody
- Conditions
- Type 1 Diabetes
- Being tested
- Gamma Aminobutyric Acid (GABA), Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma Aminobutyric Acid (GABA)Drug
Also called Gamma Aminobutyric Acid
two dosages will be used in this study. GABA: 50mg/kg/day and 100mg/kg/day
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Gamma Aminobutyric Acid (GABA) | Active comparator | GABA will be given 50mg/kg/Day, thrice daily for 52 weeks Receives: Drug: Gamma Aminobutyric Acid (GABA) |
| Gamma Aminobutyric Acid GABA) | Active comparator | GABA will be given 100mg/kg/Day, thrice daily for 52 weeks. Receives: Drug: Gamma Aminobutyric Acid (GABA) |
| placebo | Placebo comparator | placebo will be given thrice daily for 52 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide value
The primary statistical hypothesis to be assessed in this study is whether the mean C-peptide value for study subjects receiving GABA differs significantly from the mean value for placebo subjects assessed at follow-up.
Measured: baseline and up to 52 weeks
Secondary outcomes (1)
HbA1C level
The study will examine the HbA1C level every 3 months from baseline and up to 52 weeks.
Measured: baseline and up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoyun Zhang, Huashan Hospital
- Investigators
- Yiming Li, Doctor, Principal investigator, Huashan HospitalQinghua Wang, Doctor, Principal investigator, St Michale's Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781884
- Sponsor's protocol ID
- 2012-024
- Status last verified
- Jan 2013
- First submitted
- 12 Jan 2013
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile
- ClinicalTrials.gov ID
- NCT01781884
- Acronym / sponsor ID
- 2012-024
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 Feb 2013 (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.
This study is a multicenter, randomized, double-masked, placebo-controlled clinical study. All groups will receive standard intensive diabetes treatment with insulin and life style management. 60 subjects will be randomly assigned in a 1:1:1 ratio to receive placebo or different dosage of GABA.
GABA is an amino acid produced from glutamate by glutamic acid decarboxylase. It was approved for the treatment of hepatic coma, fibromyalgia, ataxia in China and is widely used as supplement for the treatment of epilepsy, insomnia, stress and tobacco dependence. It has been recently shown that GABA can prevent and reverse the development of diabetes in type 1 mice models. Participants will receive placebo or GABA for 52 weeks.
The study will consist of 4 weeks screening period, 2 weeks run-in period, 52 weeks treatment period and 4 weeks follow-up period. Enrollment is expected to occur over 2 years.
To assess the efficacy and safety of GABA for the treatment of juvenile type 1 diabetes in new onset subjects.
Detailed description
Primary Outcome:
The primary statistical hypothesis to be assessed in this study is whether the mean C-peptide value for study subjects receiving GABA differs significantly from the mean value for placebo subjects assessed at follow-up.
Secondary Outcome:
The study will examine the HbA1C and the daily dosage of insulin (units/kg).
Exploratory Endpoint:
The study will assess the effects of treatment on inflammatory markers and immunological outcomes.
Major Inclusion Criteria:
Type 1 diabetes within past 6 months Age 5-21 years* At least one diabetes associated autoantibody
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gamma Aminobutyric Acid (GABA) | Active comparator | Drug: Gamma Aminobutyric Acid (GABA)GABA will be given 50mg/kg/Day, thrice daily for 52 weeks |
| Gamma Aminobutyric Acid GABA) | Active comparator | Drug: Gamma Aminobutyric Acid (GABA)GABA will be given 100mg/kg/Day, thrice daily for 52 weeks. |
| placebo | Placebo comparator | Drug: Placeboplacebo will be given thrice daily for 52 weeks |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Be between the ages of 5 and 21 years*
- Be within 6-months of diagnosis of type 1 diabetes based on American Diabetes Association (ADA) criteria
- Must have stimulated C-peptide levels ≥0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month of randomization
- Presence of at least one diabetes-related autoantibody
- Must be willing to comply with intensive diabetes management and monitor glucose with glucometer.
Key exclusion criteria (13 listed)
- Be currently pregnant or lactating or anticipate getting pregnant during the study period.
- Type 2 diabetes and other specific types of diabetes.
- Require use of systemic immunosuppressant, steroids or other medications that can affect glucose metabolism.
- Have a history of malignancies
- Be currently using non-insulin pharmaceuticals to affect glycemic control
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 Aminobutyric Acid (GABA)Also: Gamma Aminobutyric Acidtwo dosages will be used in this study. GABA: 50mg/kg/day and 100mg/kg/day | Drug | Gamma Aminobutyric Acid (GABA), Gamma Aminobutyric Acid GABA) |
| Placebo | Drug | placebo |
Primary outcome
C-peptide value
Time frame: baseline and up to 52 weeks
The primary statistical hypothesis to be assessed in this study is whether the mean C-peptide value for study subjects receiving GABA differs significantly from the mean value for placebo subjects assessed at follow-up.
1 secondary outcome
HbA1C level
Time frame: baseline and up to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Yiming Li, Doctor principal investigator
Huashan Hospital
Qinghua Wang, Doctor principal investigator
St Michale's Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma Aminobutyric Acid (GABA) in people with Type 1 Diabetes, run by Huashan Hospital at 1 site in China.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 1 Feb 2013. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-peptide value (time frame: baseline and up to 52 weeks). 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 1 Feb 2013.