Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects
Comparison of Serum Sphingolipidomic Analyses in Healthy, Pre-diabetic and Diabetic Subjects
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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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.
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the exposure of interests are obesity, diabetes and insulin-resistance
Otros nombres:
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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
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the exposure of interests are obesity, diabetes and insulin-resistance
Otros nombres:
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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%
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the exposure of interests are obesity, diabetes and insulin-resistance
Otros nombres:
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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.
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the exposure of interests are obesity, diabetes and insulin-resistance
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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serum concentration of sphingosine-1-phosphate, micromol per liter
Periodo de tiempo: Nov, 2016
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Nov, 2016
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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serum concentration of sphingosine, micromol per liter
Periodo de tiempo: Nov, 2016
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Nov, 2016
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serum concentration of sphinganine-1-phosphate, micromol per liter
Periodo de tiempo: Nov, 2016
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Nov, 2016
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serum concentration of sphinganine, micromol per liter
Periodo de tiempo: Nov, 2016
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Nov, 2016
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serum concentration of ceramide, micromol per liter
Periodo de tiempo: Nov, 2016
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Nov, 2016
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Jing Sui, First Affiliated Hospital Xi'an Jiaotong University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KYLLSL201312701
- 13040470432 (Otro número de subvención/financiamiento: Chinese Medical Association)
- 2013YK20 (Otro número de subvención/financiamiento: The First Affiliated Hospital of Xi'an Jiaotong University)
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