Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Aarhus、丹麦、8000
- Medicinsk forskningslaboratorium, Aarhus Universitet
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male
- 18-70 years of age
- Member of Biobank Vejle
- BMI<30
Exclusion Criteria:
- Diabetes mellitus
- Severe illness
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Carriers
|
FPIR: intravenous infusion of 20 % glucose 0.3 mg/kg in 2 minutes followed by blood sampling at times 0, 2, 4, 6, 8, and 10. Duration 10 minutes. HEC: intravenous infusion of actrapid 1mU/kg/minute, simultaneous infusion of 20 % glucose at variable rate to reach plasma blood glucose level of 5 mmol/L. Duration 120 minutes Glucose tracer: bolus of 3H3glucose (12µCi) followed by infusion of 3H3glucose (0,12 µCi/min). Duration 120 minutes. Palmitate tracer:[9,10-3H]-palmitate 0,3 µCi/min. Duration 60 minutes. |
|
实验性的：Non-carriers
|
FPIR: intravenous infusion of 20 % glucose 0.3 mg/kg in 2 minutes followed by blood sampling at times 0, 2, 4, 6, 8, and 10. Duration 10 minutes. HEC: intravenous infusion of actrapid 1mU/kg/minute, simultaneous infusion of 20 % glucose at variable rate to reach plasma blood glucose level of 5 mmol/L. Duration 120 minutes Glucose tracer: bolus of 3H3glucose (12µCi) followed by infusion of 3H3glucose (0,12 µCi/min). Duration 120 minutes. Palmitate tracer:[9,10-3H]-palmitate 0,3 µCi/min. Duration 60 minutes. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
insulin secretion
大体时间：10 minutes
|
Estimation of first phase insulin secretion
|
10 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Insulin resistance
大体时间：240 minutes
|
Estimation of insulin resistance using hyperinsulinemic euglycemic clamp and glucose and lipid tracers
|
240 minutes
|
|
body composition
大体时间：60 minutes
|
Evaluation of body composition using Dxa scan and MRI scan
|
60 minutes
|
|
atherosclerosis
大体时间：30 minutes
|
Evaluation of presence and severity of atherosclerosis using ultrasound scan of the common carotide artery
|
30 minutes
|
|
biochemical blood profiling
大体时间：at baseline
|
Various tests run on blood samples
|
at baseline
|
|
Insulin resistance
大体时间：60 minutes
|
Biopsi from muscle and adipose tissue performed at baseline and during clamp study.
|
60 minutes
|
|
Blood pressure
大体时间：24 hours
|
Measurement of blood pressure every 20.
minutes/24 hours
|
24 hours
|
|
Indirect calorimetry
大体时间：60 minutes
|
Estimation of resting energy expenditure and respiratory quotient
|
60 minutes
|
合作者和调查者
合作者
调查人员
- 首席研究员：Niels Møller, Professor、University of Aarhus
- 首席研究员：Oluf B Pedersen, Professor、Steno Diabetes Center Copenhagen
- 首席研究员：Torben Hansen, Professor、Steno Diabetes Center Copenhagen
- 首席研究员：Jørgen Rungby, Professor、University of Aarhus
出版物和有用的链接
一般刊物
- Stoy J, Kampmann U, Mengel A, Magnusson NE, Jessen N, Grarup N, Rungby J, Stodkilde-Jorgensen H, Brandslund I, Christensen C, Hansen T, Pedersen O, Moller N. Reduced CD300LG mRNA tissue expression, increased intramyocellular lipid content and impaired glucose metabolism in healthy male carriers of Arg82Cys in CD300LG: a novel genometabolic cross-link between CD300LG and common metabolic phenotypes. BMJ Open Diabetes Res Care. 2015 Aug 26;3(1):e000095. doi: 10.1136/bmjdrc-2015-000095. eCollection 2015.
- Stoy J, Grarup N, Horlyck A, Ibsen L, Rungby J, Poulsen PL, Brandslund I, Christensen C, Hansen T, Pedersen O, Moller N, Kampmann U. Blood pressure levels in male carriers of Arg82Cys in CD300LG. PLoS One. 2014 Oct 14;9(10):e109646. doi: 10.1371/journal.pone.0109646. eCollection 2014.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.