Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects
NCT ID: NCT02826759
Last Updated: 2016-07-11
Study Results
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Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2016-07-31
2016-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
diabetes
the exposure of interests are obesity, diabetes and insulin-resistance
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
diabetes
the exposure of interests are obesity, diabetes and insulin-resistance
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%
diabetes
the exposure of interests are obesity, diabetes and insulin-resistance
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.
diabetes
the exposure of interests are obesity, diabetes and insulin-resistance
Interventions
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diabetes
the exposure of interests are obesity, diabetes and insulin-resistance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
Yes
Sponsors
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Chinese Medical Association
NETWORK
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Principal Investigators
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Jing Sui
Role: STUDY_DIRECTOR
First Affiliated Hospital Xi'an Jiaotong University
Locations
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The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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Sui J, He M, Wang Y, Zhao X, He Y, Shi B. Sphingolipid metabolism in type 2 diabetes and associated cardiovascular complications. Exp Ther Med. 2019 Nov;18(5):3603-3614. doi: 10.3892/etm.2019.7981. Epub 2019 Sep 6.
Other Identifiers
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13040470432
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2013YK20
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KYLLSL201312701
Identifier Type: -
Identifier Source: org_study_id
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