Pharmacokinetics Study of Gamma-aminobutyric Acid (GABA-PK)
|ClinicalTrials.gov Identifier: NCT01917760|
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : November 2, 2015
|Condition or disease||Phase|
|Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases||Phase 1|
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 Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||The Pharmacokinetics of Gamma-aminobutyric Acid in Healthy Volunteers.|
|Study Start Date :||July 2013|
|Primary Completion Date :||July 2014|
|Study Completion Date :||December 2014|
- 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:
- 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)
- serological characteristics [ Time Frame: baseline and up to 30 days ]plasma glucose levels, insulin, C-peptide and glucagon levels will be measured
- Exploratory measures [ Time Frame: baseline and up to 30 days ]plasma glucagon-like peptide-1 (GLP-1) and glycated serum protein (GSP)will be measured.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917760
|Department of Endocrinology and Metabolism，Huashan hospital|
|Shanghai, Shanghai, China, 200040|
|Principal Investigator:||Yiming Li||Huashan Hospital|
|Principal Investigator:||Qinghua Wang||Huashan Hospital/St Michael's Hospital|
|Principal Investigator:||Zheng Jiao||Huashan Hospital|