Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training (CUT-IT)
2014年8月3日 更新者：Eva Prescott
Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial
The purpose of the study is to make a head-to-head comparison of weight loss and interval training as methods of secondary prevention in overweight patients with ischemic heart disease.
研究概览
详细说明
In western countries 80 % of patients with ischemic heart disease (IHD) are overweight (BMI > 25). Weight loss using a low energy diet (LED, 800 - 1000 kcal/day) has been shown to induce a considerable weight loss in obese but otherwise healthy patients and to reduce the risk of cardiovascular disease and diabetes in these subjects. Additionally, a British study using a very low energy diet (VLED, 600 kcal/day) to obtain weight loss, has shown that subject with diagnosed type 2 diabetes had their blood glucose normalized after an 8 week VLED. However, the effect of LED has never been examined in overweight patients with IHD.
Several studies have shown that patients with IHD have a beneficial effect of exercise training regarding mortality and reduction in cardiovascular risk factors. A Norwegian group has shown that aerobic interval training results in the biggest increase in maximal oxygen uptake (VO2max). A high VO2max is correlated to decreased mortality in patients with IHD.
In conclusion, weight loss and exercise are known strategies in preventing progression of IHD and development of type 2 diabetes in these patients, however a head-to-head comparison of the two methods has never been made and it is unknown which intervention is the most effective in improving cardiovascular risk profile. Furthermore, several mechanisms behind the known beneficial effect of these interventions are unknown.
研究类型
介入性
注册 (实际的)
70
阶段
- 不适用
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
-
-
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Copenhagen、丹麦、2400
- Bispebjerg Hospital
-
-
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
45年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Stable Ischemic Heart Disease
- BMI 28 - 40 kg/m2
Exclusion criteria:
- Known Diabetes Mellitus
- Repeated Fasting plasma glucose ≥ 7 mmol/L or Hba1c > 7 %
- Severe or moderate valve disease
- Main stem stenosis
- Severe heart failure, Ejection Fraction < 35 %
- Physical or mental disability which are expected to prevent completion of intervention
- Severe Chronic obstructive Pulmonary Disease (COPD) (FEV1 < 50 % of expected) or asthma
- Active cancer
- Severe kidney (GFR < 40 ml/hour) or severe liver disease
- Severe ischemia or arrhythmias during exercise test
- 2. or 3. degree atrio-ventricular (AV) block, not protected by pacemaker
- Organised training more than 2 times a week prior to inclusion
- Significant weight loss or weight gain (> 5 %)3 month prior to inclusion
- Not able to comprehend written and oral informed consent
- Hormone treatment
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
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Weight Loss
12 weeks of Low Calorie Diet to obtain a 10 - 15 % weight loss.
Followed by 40 weeks on a weight maintenance diet and interval training 2 times a week.
|
Low calorie diet approx.
1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.
|
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实验性的：Interval Training
12 weeks of interval training 3 times a week followed by 40 weeks of interval training 2 times a week.
|
Interval training (IT) on an exercise bike 3 times a week, for the first 12 weeks, followed by 40 weeks of IT 2 times a week on exercise bike.
Each training session consists of active intervals with a total duration of 16 minutes (durations intervals between 1 and 4 minutes) at 90% of maximal heart rate.
Active intervals are separated by active pauses at 60% of maximal heart rate.
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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 |
|---|---|---|
|
Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
Assessed by a non-invasive echocardiographic Doppler measurement
|
0, 12 and 52 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Heart Rate Variability and silent ischemia following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
Assessed by Holter Monitoring for 24 - 48 hours
|
0, 12 and 52 weeks
|
|
Change in endothelial function following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
Using the Endopat 2000 from Itamar
|
0, 12 and 52 weeks
|
|
Change in systolic and diastolic function following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
Assessed by echocardiography resting and during physiological and medical stress.
|
0, 12 and 52 weeks
|
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Change in body composition following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
Assessed by anthropometry, dual X-ray absorptiometry (DXA) (lean body mass, percentage adipose tissue) and abdominal MRI (liver fat, muscle fat, subcutaneous fat and visceral fat at the level of L3).
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0, 12 and 52 weeks
|
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Change in myocardial blood flow following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
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Assessed by positron emission tomography of the heart
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0, 12 and 52 weeks
|
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Change in insulin action, beta cell function and incretin secretion following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
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A Oral Glucose Tolerance Test is performed.
|
0, 12 and 52 weeks
|
|
Change in oxidized lipids and lipoprotein particle size following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
0, 12 and 52 weeks
|
|
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Change in peak oxygen uptake (VO2max) following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
Assessed using a bicycle ergometer
|
0, 12 and 52 weeks
|
|
Change in blood pressure following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
0, 12 and 52 weeks
|
|
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Change in inflammatory markers in urin, blood and adipose tissue following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
0, 12 and 52 weeks
|
|
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Change in quality of life following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
0, 12 and 52 weeks
|
|
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Change in ceramides, diacylglycerol og endocannabinoid (CB)-1 receptors in adipose tissue following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
0, 12 and 52 weeks
|
|
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Change in hormones derived from adipose tissue following the diet or training intervention and a maintenance period
大体时间：0, 12 and 52 weeks
|
0, 12 and 52 weeks
|
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。
赞助
合作者
调查人员
- 首席研究员：Eva Prescott, MD, DMsc、Bispebjerg 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。
一般刊物
- Pedersen LR, Olsen RH, Frederiksen M, Astrup A, Chabanova E, Hasbak P, Holst JJ, Kjaer A, Newman JW, Walzem R, Wisloff U, Sajadieh A, Haugaard SB, Prescott E. Copenhagen study of overweight patients with coronary artery disease undergoing low energy diet or interval training: the randomized CUT-IT trial protocol. BMC Cardiovasc Disord. 2013 Nov 19;13:106. doi: 10.1186/1471-2261-13-106.
- Pedersen LR, Olsen RH, Jurs A, Astrup A, Chabanova E, Simonsen L, Wisloff U, Haugaard SB, Prescott E. A randomised trial comparing weight loss with aerobic exercise in overweight individuals with coronary artery disease: The CUT-IT trial. Eur J Prev Cardiol. 2015 Aug;22(8):1009-17. doi: 10.1177/2047487314545280. Epub 2014 Jul 31.
- Pedersen LR, Olsen RH, Anholm C, Astrup A, Eugen-Olsen J, Fenger M, Simonsen L, Walzem RL, Haugaard SB, Prescott E. Effects of 1 year of exercise training versus combined exercise training and weight loss on body composition, low-grade inflammation and lipids in overweight patients with coronary artery disease: a randomized trial. Cardiovasc Diabetol. 2019 Oct 1;18(1):127. doi: 10.1186/s12933-019-0934-x.
- Pedersen LR, Olsen RH, Anholm C, Walzem RL, Fenger M, Eugen-Olsen J, Haugaard SB, Prescott E. Weight loss is superior to exercise in improving the atherogenic lipid profile in a sedentary, overweight population with stable coronary artery disease: A randomized trial. Atherosclerosis. 2016 Mar;246:221-8. doi: 10.1016/j.atherosclerosis.2016.01.001. Epub 2016 Jan 13.
- Pedersen LR, Olsen RH, Jurs A, Anholm C, Fenger M, Haugaard SB, Prescott E. A randomized trial comparing the effect of weight loss and exercise training on insulin sensitivity and glucose metabolism in coronary artery disease. Metabolism. 2015 Oct;64(10):1298-307. doi: 10.1016/j.metabol.2015.07.007. Epub 2015 Jul 17.
- Olsen RH, Pedersen LR, Jurs A, Snoer M, Haugaard SB, Prescott E. A randomised trial comparing the effect of exercise training and weight loss on microvascular function in coronary artery disease. Int J Cardiol. 2015 Apr 15;185:229-35. doi: 10.1016/j.ijcard.2015.03.118. Epub 2015 Mar 11.
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9月1日
初级完成 (实际的)
2014年4月1日
研究完成 (实际的)
2014年4月1日
研究注册日期
首次提交
2012年10月26日
首先提交符合 QC 标准的
2012年11月7日
首次发布 (估计)
2012年11月12日
研究记录更新
最后更新发布 (估计)
2014年8月5日
上次提交的符合 QC 标准的更新
2014年8月3日
最后验证
2014年8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.