Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- 未提供
结局指标
主要结局
Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period
时间窗: 0, 12 and 52 weeks
Assessed by a non-invasive echocardiographic Doppler measurement
次要结局
- Change in body composition following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in peak oxygen uptake (VO2max) following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in blood pressure following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in ceramides, diacylglycerol og endocannabinoid (CB)-1 receptors in adipose tissue following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in Heart Rate Variability and silent ischemia following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in endothelial function following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in myocardial blood flow following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in inflammatory markers in urin, blood and adipose tissue following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in systolic and diastolic function following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in insulin action, beta cell function and incretin secretion following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in hormones derived from adipose tissue following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in oxidized lipids and lipoprotein particle size following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
- Change in quality of life following the diet or training intervention and a maintenance period(0, 12 and 52 weeks)
研究者
Eva Prescott
MD, MDsc
Bispebjerg Hospital