- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826759
Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects
Comparison of Serum Sphingolipidomic Analyses in Healthy, Pre-diabetic and Diabetic Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: jing Sui
- Phone Number: 0086-18991989230
- Email: suijing1029@163.com
Study Locations
-
-
Shaanxi
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Xi'an, Shaanxi, China, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Contact:
- Bingyin Shi
- Phone Number: 0086-13700298366
- Email: shibingy@126.com
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Contact:
- jing Sui
- Phone Number: 0086-18991989230
- Email: suijing1029@163.com
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Principal Investigator:
- Huairong Zhang
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
the exposure of interests are obesity, diabetes and insulin-resistance
Other Names:
|
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
|
the exposure of interests are obesity, diabetes and insulin-resistance
Other Names:
|
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%
|
the exposure of interests are obesity, diabetes and insulin-resistance
Other Names:
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum concentration of sphingosine-1-phosphate, micromol per liter
Time Frame: Nov, 2016
|
Nov, 2016
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum concentration of sphingosine, micromol per liter
Time Frame: Nov, 2016
|
Nov, 2016
|
serum concentration of sphinganine-1-phosphate, micromol per liter
Time Frame: Nov, 2016
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Nov, 2016
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serum concentration of sphinganine, micromol per liter
Time Frame: Nov, 2016
|
Nov, 2016
|
serum concentration of ceramide, micromol per liter
Time Frame: Nov, 2016
|
Nov, 2016
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Jing Sui, First Affiliated Hospital Xi'an Jiaotong University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KYLLSL201312701
- 13040470432 (Other Grant/Funding Number: Chinese Medical Association)
- 2013YK20 (Other Grant/Funding Number: The First Affiliated Hospital of Xi'an Jiaotong University)
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