- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02826759
Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects
Comparison of Serum Sphingolipidomic Analyses in Healthy, Pre-diabetic and Diabetic Subjects
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Shaanxi
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Xi'an, Shaanxi, 중국, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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.
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the exposure of interests are obesity, diabetes and insulin-resistance
다른 이름들:
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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
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the exposure of interests are obesity, diabetes and insulin-resistance
다른 이름들:
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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%
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the exposure of interests are obesity, diabetes and insulin-resistance
다른 이름들:
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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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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serum concentration of sphingosine-1-phosphate, micromol per liter
기간: Nov, 2016
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Nov, 2016
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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serum concentration of sphingosine, micromol per liter
기간: Nov, 2016
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Nov, 2016
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serum concentration of sphinganine-1-phosphate, micromol per liter
기간: Nov, 2016
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Nov, 2016
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serum concentration of sphinganine, micromol per liter
기간: Nov, 2016
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Nov, 2016
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serum concentration of ceramide, micromol per liter
기간: Nov, 2016
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Nov, 2016
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공동 작업자 및 조사자
수사관
- 연구 책임자: Jing Sui, First Affiliated Hospital Xi'an Jiaotong University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .