Diabetes MellitusGABA-PKNCT01917760
Pharmacokinetics Study of Gamma-aminobutyric Acid
An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Huashan Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine upon administering GABA orally to a person how it is absorbed, distributed, as well as the drug's pharmacological effects on the body such as glucose levels, serum C-peptide and/or insulin levels (referred to as pharmacokinetics/pharmacodynamics). Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Dec 2014
- Phase
- Observational
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents of Shanghai
Who may be able to join
- Volunteers in good health condition between 19 and 40 years of age (inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 24 kg/m2 (inclusive), with weight greater than 50 kg.
- Not on any medication 2 weeks before screening.
- No blood donation within 3 months before screening.
- Must sign the informed consent. Note: Blood and biochemical tests must be normal during the screening. However, if the participant's test-results were beyond the normal range, the individual can still be recruited as long as the results do not affect the experiment.
Who cannot join
- Abnormalities of physical examination, laboratory tests, or ECG in screening, which may influence the results of the study.
- Previous or existing history of severe heart, liver, kidney, gastrointestinal, nervous system, mental, or metabolic abnormalities as well as other diseases which can affect drug absorption, circulation, metabolism, or excretion.
- History of alcoholism, smoking, or drug abuse within the past 1 year.
- Participation in any clinical drug study within the past 30 days.
- Any definite or suspected allergy or family history of allergy to GABA or any other similar drugs.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology and Metabolism，Huashan hospital
Shanghai, Shanghai Municipality, 200040
About this study
Official title: The Pharmacokinetics of Gamma-aminobutyric Acid in Healthy Volunteers.
The purpose of this study is to determine upon administering GABA orally to a person how it is absorbed, distributed, as well as the drug's pharmacological effects on the body such as glucose levels, serum C-peptide and/or insulin levels (referred to as pharmacokinetics/pharmacodynamics). We will conduct experiments in normal subjects to address these questions.
Read the detailed description
Type 1 diabetes is an autoimmune disease resulting from the progressive loss of pancreatic insulin-secreting beta-cells. This consequently leads to a lack of insulin and elevation of blood sugar, namely hyperglycemia, which is a major cause for the development of diabetes and its acute or chronic complications. The current treatment for type 1 diabetes requires a life-long dependency on daily insulin injections, causing inconvenience and burden to patients. Drug-induced hypoglycemia is also common as it presents a major challenge in insulin therapy. Furthermore, although insulin therapy is lifesaving, it is not a cure as it neither reverses the progression of the disease nor prevents the development of serious complications associated with this disease. New treatments are urgently needed.
Recent studies have demonstrated that a natural chemical found in the brain, gamma-aminobutyric acid (GABA), which is also produced in large quantities by pancreatic beta-cells, has beta-cell regenerative and immunoregulatory effects. Importantly, GABA prevented and partially reversed diabetes in type 1 diabetes mouse models. It is important to address essential questions regarding the potential effects of GABA in diabetic patients in humans. Given the largely unknown mechanism of action of GABA in the pancreas, and the limited information on how GABA is absorbed, distributed and eliminated from the human body, we plan to examine these issues (referred to as pharmacokinetics/pharmacodynamics) in normal subjects.
The outcome of this study will provide useful information on the mechanism of action of GABA in human subjects.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases
- Keywords
- Gamma-aminobutyric acid, Pharmacokinetics, Pharmacodynamics, Insulin, C-peptide, Glucagon
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic characteristics of γ-aminobutyric acid (GABA)
The primary endpoint of this study is to obtain the pharmacokinetic characteristics of γ-aminobutyric acid (GABA), including:
- Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t),
- Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞),
- Maximum observed plasma concentration (Cmax),
- Time to maximum plasma concentration (Tmax), and
- Terminal elimination half-life in plasma (t½)
Measured: baseline and up to 30 days
Secondary outcomes (1)
serological characteristics
plasma glucose levels, insulin, C-peptide and glucagon levels will be measured
Measured: baseline and up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionDec 2014
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 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoyun Zhang, Huashan Hospital
- Investigators
- Yiming Li, Principal investigator, Huashan HospitalQinghua Wang, Principal investigator, Huashan Hospital/St Michael's HospitalZheng Jiao, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917760
- Sponsor's protocol ID
- KY-2013-222
- Other IDs
- JDRF_17-2013-499
- Acronym
- GABA-PK
- Status last verified
- Oct 2015
- First submitted
- 6 Jul 2013
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of Gamma-aminobutyric Acid in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01917760
- Acronym / sponsor ID
- GABA-PK / KY-2013-222
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases
- Keywords
- Gamma-aminobutyric acid, Pharmacokinetics, Pharmacodynamics, Insulin, C-peptide, Glucagon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Unity Health Toronto, University of Florida, University of Massachusetts, Worcester
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Aug 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.
The purpose of this study is to determine upon administering GABA orally to a person how it is absorbed, distributed, as well as the drug's pharmacological effects on the body such as glucose levels, serum C-peptide and/or insulin levels (referred to as pharmacokinetics/pharmacodynamics). We will conduct experiments in normal subjects to address these questions.
Detailed description
Type 1 diabetes is an autoimmune disease resulting from the progressive loss of pancreatic insulin-secreting beta-cells. This consequently leads to a lack of insulin and elevation of blood sugar, namely hyperglycemia, which is a major cause for the development of diabetes and its acute or chronic complications. The current treatment for type 1 diabetes requires a life-long dependency on daily insulin injections, causing inconvenience and burden to patients. Drug-induced hypoglycemia is also common as it presents a major challenge in insulin therapy. Furthermore, although insulin therapy is lifesaving, it is not a cure as it neither reverses the progression of the disease nor prevents the development of serious complications associated with this disease. New treatments are urgently needed.
Recent studies have demonstrated that a natural chemical found in the brain, gamma-aminobutyric acid (GABA), which is also produced in large quantities by pancreatic beta-cells, has beta-cell regenerative and immunoregulatory effects. Importantly, GABA prevented and partially reversed diabetes in type 1 diabetes mouse models. It is important to address essential questions regarding the potential effects of GABA in diabetic patients in humans. Given the largely unknown mechanism of action of GABA in the pancreas, and the limited information on how GABA is absorbed, distributed and eliminated from the human body, we plan to examine these issues (referred to as pharmacokinetics/pharmacodynamics) in normal subjects.
The outcome of this study will provide useful information on the mechanism of action of GABA in human subjects.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents of Shanghai
Key inclusion criteria (5 listed)
- Volunteers in good health condition between 19 and 40 years of age (inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 24 kg/m2 (inclusive), with weight greater than 50 kg.
- Not on any medication 2 weeks before screening.
- No blood donation within 3 months before screening.
- Must sign the informed consent. Note: Blood and biochemical tests must be normal during the screening. However, if the participant's test-results were beyond the normal range, the individual can still be recruited as long as the results do not affect the experiment.
Key exclusion criteria (5 listed)
- Abnormalities of physical examination, laboratory tests, or ECG in screening, which may influence the results of the study.
- Previous or existing history of severe heart, liver, kidney, gastrointestinal, nervous system, mental, or metabolic abnormalities as well as other diseases which can affect drug absorption, circulation, metabolism, or excretion.
- History of alcoholism, smoking, or drug abuse within the past 1 year.
- Participation in any clinical drug study within the past 30 days.
- Any definite or suspected allergy or family history of allergy to GABA or any other similar drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pharmacokinetic characteristics of γ-aminobutyric acid (GABA)
Time frame: baseline and up to 30 days
The primary endpoint of this study is to obtain the pharmacokinetic characteristics of γ-aminobutyric acid (GABA), including: 1. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t), 2. Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞), 3. Maximum observed plasma concentration (Cmax), 4. Time to maximum plasma concentration (Tmax), and 5. Terminal elimination half-life in plasma (t½)
1 secondary outcome
serological characteristics
Time frame: baseline and up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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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.
Yiming Li principal investigator
Huashan Hospital
Qinghua Wang principal investigator
Huashan Hospital/St Michael's Hospital
Zheng Jiao principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 1, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 2 Nov 2015. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pharmacokinetic characteristics of γ-aminobutyric acid (GABA) (time frame: baseline and up to 30 days). 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 2 Nov 2015.