Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02826759
• Other study ID #: KYLLSL201312701
• Secondary ID: 130404704322013Y
• Status: Not yet recruiting
• Phase: N/A
• First received: July 6, 2016
• Last updated: July 7, 2016
• Start date: July 2016
• Est. completion date: November 2016

Study information

• Verified date: April 2016
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jing Sui
• Phone: 0086-18991989230
• Email: suijing1029[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum concentration of sphingosine-1-phosphate, micromol per liter		Nov, 2016	No
Secondary	serum concentration of sphingosine, micromol per liter		Nov, 2016	No
Secondary	serum concentration of sphinganine-1-phosphate, micromol per liter		Nov, 2016	No
Secondary	serum concentration of sphinganine, micromol per liter		Nov, 2016	No
Secondary	serum concentration of ceramide, micromol per liter		Nov, 2016	No