Trials / Completed

CompletedNCT01917760

Pharmacokinetics Study of Gamma-aminobutyric Acid

The Pharmacokinetics of Gamma-aminobutyric Acid in Healthy Volunteers.

Status: Completed
Phase: —
Study type: Observational
Enrollment: 12 (actual)

Sponsor: Huashan Hospital · Academic / Other
Sex: All
Age: 19 Years – 40 Years
Healthy volunteers: Accepted

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). 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.

Conditions

Timeline

Start date: 2013-07-01
Primary completion: 2014-07-01
Completion: 2014-12-01
First posted: 2013-08-07
Last updated: 2015-11-02

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01917760. Inclusion in this directory is not an endorsement.