Pharmacokinetics Study of Gamma-aminobutyric Acid (GABA-PK)
The Pharmacokinetics of Gamma-aminobutyric Acid in Healthy Volunteers.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Shanghai
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Shanghai, Shanghai, China, 200040
- Department of Endocrinology and Metabolism，Huashan hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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pharmacokinetic characteristics of γ-aminobutyric acid (GABA)
Prazo: baseline and up to 30 days
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The primary endpoint of this study is to obtain the pharmacokinetic characteristics of γ-aminobutyric acid (GABA), including:
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baseline and up to 30 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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serological characteristics
Prazo: baseline and up to 30 days
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plasma glucose levels, insulin, C-peptide and glucagon levels will be measured
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baseline and up to 30 days
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Exploratory measures
Prazo: baseline and up to 30 days
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plasma glucagon-like peptide-1 (GLP-1) and glycated serum protein (GSP)will be measured.
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baseline and up to 30 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yiming Li, Huashan Hospital
- Investigador principal: Qinghua Wang, Huashan Hospital/St Michael's Hospital
- Investigador principal: Zheng Jiao, Huashan Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KY-2013-222
- JDRF_17-2013-499 (Identificador de registro: Juvenile Diabetes Research Foundation International (JDRF)])
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