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Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02826759
Enrollment
200
Registered
2016-07-11
Start date
2016-07-31
Completion date
2016-11-30
Last updated
2016-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Prediabetic State

Keywords

sphingolipid, diabetes mellitus, biomarker, obesity, insulin resistance

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.

Interventions

OTHERdiabetes

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

Sponsors

Chinese Medical Association
CollaboratorNETWORK
First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
serum concentration of sphingosine-1-phosphate, micromol per literNov, 2016

Secondary

MeasureTime frame
serum concentration of sphingosine, micromol per literNov, 2016
serum concentration of sphinganine-1-phosphate, micromol per literNov, 2016
serum concentration of sphinganine, micromol per literNov, 2016
serum concentration of ceramide, micromol per literNov, 2016

Countries

China

Contacts

Primary ContactJing Sui
suijing1029@163.com0086-18991989230

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026