Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects
Comparison of Serum Sphingolipidomic Analyses in Healthy, Pre-diabetic and Diabetic Subjects
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The first purpose of this study is to determine whether serum sphingolipid metabolites associate significantly with the weight among type 2 diabetes. 60 patients with diagnosed type 2 diabetes will be recruited. The serum concentrations of sphingolipid metabolites of 20 type 2 diabetic patients with obesity will be compared to age- and sex-matched series of 40 type 2 patients without obesity.
The second purpose of this study is to determine whether serum sphingolipid metabolites associate significantly with the process and severity of type 2 diabetes. The serum concentrations of sphingolipid metabolites of 20 subjects with type 2 diabetes will be compared to age-, sex- and BMI-matched series of healthy and pre-diabetic subjects. Investigators speculate that the serum concentration of sphingolipid metabolites are positively related with the progression of diabetes. In order to discover why serum sphingolipid metabolites correlates with the progression of diabetes, detailed information on HbA1c, duration of diabetes history and insulin resistance defined by homeostatic model assessment (HOMA-IR) will be analysed. These three parameters may affect the serum concentrations of sphingolipid metabolites.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
subjects undergoing oral glucose tolerance test and hospitalized type 2 diabetic patients in the Dpartment of Endocrinology in the First Affiliated Hospital of Xi'an Jiaotong Unversity are collected.
healthy subjects undergoing routine physical exam in the department of medical examination center, First Affiliated Hospital of Xi'an Jiaotong Unversity are recruited
Descrição
Inclusion Criteria:
- clinical diagnosis of diabetes mellitus, type 2
- clinical diagnosis of prediabetic status
- older than 18 and younger than 90 years-old
- clinical diagnosis of insulin-resistance
- clinical diagnosis of newly onset of diabetes mellitus, type 2
- those who are willing to participate in the trial and sign the consent form
Exclusion Criteria:
- any cardiovascular disease (myocardial infarction, heart failure, cerebrovascular accident)
- missing information of BMI
- sever liver, kidney dysfunction
- sever pancreatitis or those who received pancreatectomy
- on medications of hormone, immunosuppressive therapy or drugs that may affect the bioactivity or concentration of sphingolipids (e.g. asprin )
- patients on pregnancy
- sever systematic diseases including carcinoma, mental disorder, sever anemia et al.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
serum sphingolipid metabolites in healthy subjects
Healthy subjects are classified according to BMI into three subgroups: healthy normal weight subjects, healthy overweight subjects and healthy subjects with obesity.
Age and sex are matched among three subgroups.
serum sphingolipid metabolites including sphingosine-1-phosphate will be compared.
|
|
|
serum sphingolipid metabolites in diabetic subjects
Diagnosed diabetic patients are divided into three subgroups: diabetic patients with normal weight, overweight and obesity.
age and sex are matched.
|
the exposure of interests are obesity, diabetes and insulin-resistance
Outros nomes:
|
|
serum sphingolipid metabolites in the progression of diabetes
serum sphingolipid metabolites are compared among three age-, sex- and body mass index-matched subgroups: healthy subjects, subjects with pre-diabetes, subjects with diabetes
|
the exposure of interests are obesity, diabetes and insulin-resistance
Outros nomes:
|
|
serum sphingolipid metabolites and HbA1c
diabetic subjects are divided by HbA1c level.
the cut-offs are 7% and 9%.
serum sphingolipid metabolites will be tested among diabetic patients with HbA1c <7%, 7%-9% and >9%
|
the exposure of interests are obesity, diabetes and insulin-resistance
Outros nomes:
|
|
serum sphingolipid metabolites in insulin-resistant subjects
comparison of serum sphingolipid metabolites in newly diagnosed insulin-resistant subjects and age-, sex- and BMI-matched healthy controls.
|
the exposure of interests are obesity, diabetes and insulin-resistance
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
serum concentration of sphingosine-1-phosphate, micromol per liter
Prazo: Nov, 2016
|
Nov, 2016
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
serum concentration of sphingosine, micromol per liter
Prazo: Nov, 2016
|
Nov, 2016
|
|
serum concentration of sphinganine-1-phosphate, micromol per liter
Prazo: Nov, 2016
|
Nov, 2016
|
|
serum concentration of sphinganine, micromol per liter
Prazo: Nov, 2016
|
Nov, 2016
|
|
serum concentration of ceramide, micromol per liter
Prazo: Nov, 2016
|
Nov, 2016
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Jing Sui, First Affiliated Hospital Xi'an Jiaotong University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
- KYLLSL201312701
- 13040470432 (Número de outro subsídio/financiamento: Chinese Medical Association)
- 2013YK20 (Número de outro subsídio/financiamento: The First Affiliated Hospital of Xi'an Jiaotong University)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .