Diabetes Mellitus Clinical Trial
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.
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.
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