Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects
Comparison of Serum Sphingolipidomic Analyses in Healthy, Pre-diabetic and Diabetic Subjects
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
Shaanxi
-
Xi'an、Shaanxi、中国、710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
|
|
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
他の名前:
|
|
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
他の名前:
|
|
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
他の名前:
|
|
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.
|
the exposure of interests are obesity, diabetes and insulin-resistance
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
serum concentration of sphingosine-1-phosphate, micromol per liter
時間枠:Nov, 2016
|
Nov, 2016
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
serum concentration of sphingosine, micromol per liter
時間枠:Nov, 2016
|
Nov, 2016
|
|
serum concentration of sphinganine-1-phosphate, micromol per liter
時間枠:Nov, 2016
|
Nov, 2016
|
|
serum concentration of sphinganine, micromol per liter
時間枠:Nov, 2016
|
Nov, 2016
|
|
serum concentration of ceramide, micromol per liter
時間枠:Nov, 2016
|
Nov, 2016
|
協力者と研究者
捜査官
- スタディディレクター:Jing Sui、First Affiliated Hospital Xi'an Jiaotong University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。