Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects

• Conditions: Prediabetic State; Diabetes Mellitus, Type 2
• Interventions: Other: diabetes

• Registration Number: NCT02826759
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

This study is designed to compare the serum sphingolipidomic analyses in healthy, pre-diabetic and diabetic subjects. age, sex and BMI are matched among these three groups. As ceramide, sphingosine, sphingosine-1-phosphate and sphinganine are involved in inflammation, immunity and cancer, investigators proposed a hypothesis that sphingosine-1-phosphate and other sphingolipids may be associated with the progress of type 2 diabetes. sphingolipids may be a biomarker for diabetes.

Detailed Description

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.

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-07
• Last Update Submitted: 2016-07-07
• Study First Posted: 2016-07-11
• Last Update Posted: 2016-07-11
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
serum sphingolipid metabolites in insulin-resistant subjects	diabetes	comparison of serum sphingolipid metabolites in newly diagnosed insulin-resistant subjects and age-, sex- and BMI-matched healthy controls.
serum sphingolipid metabolites in diabetic subjects	diabetes	Diagnosed diabetic patients are divided into three subgroups: diabetic patients with normal weight, overweight and obesity. age and sex are matched.
serum sphingolipid metabolites in the progression of diabetes	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
serum sphingolipid metabolites and HbA1c	diabetes	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%

Primary Outcome Measures

Name	Time	Method
serum concentration of sphingosine-1-phosphate, micromol per liter	Nov, 2016

Secondary Outcome Measures

Name	Time	Method
serum concentration of sphingosine, micromol per liter	Nov, 2016
serum concentration of sphinganine, micromol per liter	Nov, 2016
serum concentration of sphinganine-1-phosphate, micromol per liter	Nov, 2016
serum concentration of ceramide, micromol per liter	Nov, 2016

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China