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Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow up (INFO)

2019年9月20日 更新者:Tonje Amb Aksnes、Oslo University Hospital

Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow-up

The purpose of this study is to identify risk factors for insulin resistance and to investigate the influence of insulin sensitivity on development of cardiovascular risk markers like blood pressure, heart rate, body build (weight, BMI, waist-hip ratio, skinfold thickness), reduced insulin sensitivity, diabetes mellitus, dyslipidaemia, and sympathoadrenal activity or manifest cardiovascular disease among young men during 10-20 years.

研究概览

地位

完全的

详细说明

In 1988 Reaven described a syndrome designed "syndrome X" based on the clustering of resistance to insulin-stimulated glucose uptake, hyperinsulinaemia, hyperglycaemia, increased triglycerides, decreased high-density lipoprotein (HDL) cholesterol and high blood pressure and proposed insulin resistance as the common feature and the aetiology of the syndrome. Later obesity and the sympathetic nervous system have been proposed as pathogenic factors of the metabolic syndrome, and still major controversy exists regarding its precise aetiology and different definitions of metabolic syndrome are also discussed.

Insulin resistance is a growing epidemic concern in both industrialized and developing countries. It is one of the components of the metabolic syndrome, and plays an important role in the pathogenesis of type 2 diabetes. In view of the predicted increase in the number of diabetic patients during the coming decades, further information about risk factors and pathophysiology of diabetes are of utmost importance for early detection and possible prevention and early treatment from both a medical and a financial perspective. Our research group has for decades studied the pathophysiology of insulin resistance, hypertension, sympathoadrenal hyperreactivity and dyslipidaemia. We have also recently finished a long-term follow up study of subjects based on their cardiovascular and sympathetic responses to mental stress.

During 1991-2002 healthy young men recruited from the military enlistments in the Oslo/Akershus area were examined at Center of Cardiovascular and Renal Research, Division of Medicine, Oslo University Hospital, Ullevål. Young, healthy men, mean age of 21, were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique, which is the gold standard to assess insulin sensitivity. The present study aims to re-examine these subjects in order to investigate the influence of insulin sensitivity on development of cardiovascular risk factors and diabetes. We therefore have a unique opportunity to perform a true, long-term follow-up study of a homogenous sample of subjects of same race and gender which may provide new insights into various pathophysiological mechanisms in diabetes and cardiovascular disease including elucidating the connections between insulin resistance, changes in parameters of body build, blood pressure and sympathetic over-activity. Clarifying these mechanisms are of direct importance for the entire population. There has to our knowledge not been any previous long-term follow-up on subjects based on their insulin resistance measured with this gold standard technique.

We now want to re-examine the same subject to investigate the influence of insulin sensitivity on development of cardiovascular risk factors like blood pressure, heart rate, body build (weight, BMI, waist-hip ration, skinfold thickness), reduced insulin sensitivity, diabetes mellitus, dyslipidaemia, and sympathoadrenal activity or manifest cardiovascular disease among young men during 10-20 years of follow-up.

研究类型

观察性的

注册 (实际的)

103

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Oslo、挪威、0407
        • Section of Cardiovascular and Renal Research

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

取样方法

非概率样本

研究人群

103 men previously examined with hyperinsulinemic glucose clamp, measuring insulin sensitivity, at Center of Cardiovascular and Renal Research, Division of Medicine, Oslo University Hospital, Ullevål.

描述

Inclusion Criteria:

  • Completed hyperinsulinemic glucose clamp

Exclusion Criteria:

  • Missing agreement
  • No contact information

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Longitudinal Insulin Sensitivity
The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.

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
Exploring Insulin Sensitivity After 10-20 Years of Follow-up
大体时间:One-day visit and the analyses will be done when all patients are examined in the period 2012-2013
The primary outcome is insulin sensitivity measured as the glucose disposal rate (GDR) (mg/kg/min), calculated from the average glucose infusion rate during the last 20 minutes of a 120 minutes hyperinsulinaemic isoglycaemic glucose clamp.
One-day visit and the analyses will be done when all patients are examined in the period 2012-2013
Exploring Insulin Sensitivity After 10-20 Years of Follow-up
大体时间:20 years
The primary outcome is insulin sensitivity measured as the glucose disposal rate (GDR) (mg/kg/min), calculated from the average glucose infusion rate during the last 20 minutes of a 120 minutes hyperinsulinaemic isoglycaemic glucose clamp.
20 years

次要结果测量

结果测量
措施说明
大体时间
Sympathoadrenal Activity During Rest and Stress Tests
大体时间:One-day visit and analyses will be done during 2012-2013
A mental arithmetic stress test will be announced and performed immediately after the glucose clamp, to assess the effects of increased adrenaline and noradrenaline when hepatic glucose production is suppressed by hyperinsulinaemia. Blood pressure, heart rate and catecholamine blood-levels are measured at pre-defined intervals.
One-day visit and analyses will be done during 2012-2013
Echocardiography
大体时间:One-day visit, final analyses 2012-2013
Transthoracic echocardiography will be performed using a VIVID E9 (or VIVID 7) echocardiographic scanner (GE Vingmed, Horten) with 1,7-MHz probe in second harmonic mode and optimal gain and contrast.Left ventricular (LV) internal dimension, intraventricular septal thickness and LV posterior wall thickness will be measured as well as epicardial adipose tissue. We will also evaluate biplane Simpson ejection fraction and valvular incompetence
One-day visit, final analyses 2012-2013
Ultrasound Abdomen
大体时间:One-day visit. Final analyses of the whole cohort during 2012-2013
Ultrasound quantification of abdominal adipose tissue
One-day visit. Final analyses of the whole cohort during 2012-2013

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Sverre E Kjeldsen, PhD、Oslo Univeristy Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年8月1日

初级完成 (实际的)

2014年3月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2011年7月22日

首先提交符合 QC 标准的

2011年8月8日

首次发布 (估计)

2011年8月9日

研究记录更新

最后更新发布 (实际的)

2019年10月10日

上次提交的符合 QC 标准的更新

2019年9月20日

最后验证

2019年9月1日

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.

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