Comparison of Serum Sphingolipidomic Analyses in Healthy, Pre-diabetic and Diabetic Subjects

Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects

Sponsors

Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University

Collaborator: Chinese Medical Association

Source 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.

Overall Status Unknown status
Start Date July 2016
Completion Date November 2016
Primary Completion Date November 2016
Study Type Observational
Primary Outcome
Measure Time Frame
serum concentration of sphingosine-1-phosphate, micromol per liter Nov, 2016
Secondary Outcome
Measure Time Frame
serum concentration of sphingosine, micromol per liter Nov, 2016
serum concentration of sphinganine-1-phosphate, micromol per liter Nov, 2016
serum concentration of sphinganine, micromol per liter Nov, 2016
serum concentration of ceramide, micromol per liter Nov, 2016
Enrollment 200
Condition
Intervention

Intervention type: Other

Intervention name: diabetes

Description: the exposure of interests are obesity, diabetes and insulin-resistance

Other name: insulin-resistance

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jing Sui Study Director First Affiliated Hospital Xi'an Jiaotong University
Overall Contact

Last name: Jing Sui

Phone: 0086-18991989230

Email: [email protected]

Location
facility contact contact_backup investigator The First Affiliated Hospital of Xi'an Jiaotong University Bingyin Shi 0086-13700298366 [email protected] Huairong Zhang Principal Investigator
Location Countries

China

Verification Date

April 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: serum sphingolipid metabolites in healthy subjects

Description: 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.

Arm group label: serum sphingolipid metabolites in diabetic subjects

Description: Diagnosed diabetic patients are divided into three subgroups: diabetic patients with normal weight, overweight and obesity. age and sex are matched.

Arm group label: serum sphingolipid metabolites in the progression of diabetes

Description: serum sphingolipid metabolites are compared among three age-, sex- and body mass index-matched subgroups: healthy subjects, subjects with pre-diabetes, subjects with diabetes

Arm group label: serum sphingolipid metabolites and HbA1c

Description: 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%

Arm group label: serum sphingolipid metabolites in insulin-resistant subjects

Description: comparison of serum sphingolipid metabolites in newly diagnosed insulin-resistant subjects and age-, sex- and BMI-matched healthy controls.

Study Design Info

Observational model: Case Control

Time perspective: Prospective

Source: ClinicalTrials.gov