Exercise Study on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction
The Effect of Aerobic Interval Training on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction
The aim of the study is to compare the effects of aerobic interval training and the IDF recommendations on physical activity on cardiac function and CV risk factors in patients with diabetes. The hypothesis is that AIT more than MCT, will improve myocardial dysfunction in patients with subclinical LV disease, improve both endothelial function and VO2max and thus reducing CV risk factors and CV disease. HbA1c will be more stable.
The aims of this study are to address the exercise prescription recommendations for patients with (T2DM) who have subclinical heart disease. The prescription recommendations will be assessed by randomising T2DM patients with subclinical heart disease to one of the following 2 groups for 3 months followed by a 9 month home-based program:
Moderate Intensity Exercise Group (ME). Home exercise equivalent to the present exercise recommendations of the International Diabetes Federation.
Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved through high-intensity interval training.
研究概览
详细说明
The investigators primary hypotheses are that in patients with type 2 diabetes and subclinical heart disease:
Moderate Intensity Exercise will:
Not significantly improve myocardial function compared to controls,
Despite significant improvement (compared to controls) in:
Glycaemic control (HbA1c) Cardiorespiratory fitness (VO2max) Body composition (DXA)
Aerobic Interval Training Group will:
Significantly improve myocardial function compared to controls,
Significantly improve (compared to moderate intensity exercise group):
Glycaemic control (HbA1c) Cardiorespiratory fitness (VO2max) Body composition (DXA)
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Sør-Trøndelag
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Trondheim、Sør-Trøndelag、挪威、7491
- Institutt for sirkulasjon og bildediagnostikk, Det medisinske fakultet,NTNU, Postboks 8905
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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:
- Patients 20-60 years with diagnose diabetes mellitus type 2 (without insulin) for less than 10 years and with diastolic dysfunction (E'<8), will be included.
Exclusion Criteria:
- Overt CV disease
- History of CAD
- Moderate to severe valvular disease (AI MI 3-4, AS peak gradient > 15 mmHg=2m/s)
- Atrial fibrillation or other severe arrhythmia
- Congenital heart disease
- Untreated hypertension >140/90
- LVH
- Retinopathy
- Neuropathy
- Micro or macroalbuminuria
- EF < 40%
- BMI >35
- Ischemia at exercise echocardiography
- Disease or disability making training difficult.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：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 |
|---|---|
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其他：. Moderate Intensity Exercise Group
Exercise equivalent to the current exercise guidelines.
In total 210 minutes per week of continuous moderate intensity (70% HRmax) exercise.
Home based training.
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其他：Aerobic interval training
Exercise equivalent to the current guidelines achieved through high-intensity interval training.The exercise starts with warming-up for 10-min at 70% of HRmax before performing 4x4min intervals at 90-95% of HRmax, with 3-min active recovery at 70% of HRmax between each interval, and a 5-min cool-down period, giving a total of 40-min.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Early diastolic tissue velocity (e')
大体时间：3 months
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3 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Early diastolic tissue velocity (e')
大体时间：1 year
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1 year
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合作者和调查者
调查人员
- 首席研究员：Charlotte B Ingul, PhD、NTNU, Det medisinske fakultet, Institutt for sirkulasjon og bildediagnostikk
出版物和有用的链接
一般刊物
- Hollekim-Strand SM, Bjorgaas MR, Albrektsen G, Tjonna AE, Wisloff U, Ingul CB. High-intensity interval exercise effectively improves cardiac function in patients with type 2 diabetes mellitus and diastolic dysfunction: a randomized controlled trial. J Am Coll Cardiol. 2014 Oct 21;64(16):1758-60. doi: 10.1016/j.jacc.2014.07.971. No abstract available.
- Mallard AR, Hollekim-Strand SM, Coombes JS, Ingul CB. Exercise intensity, redox homeostasis and inflammation in type 2 diabetes mellitus. J Sci Med Sport. 2017 Oct;20(10):893-898. doi: 10.1016/j.jsams.2017.03.014. Epub 2017 Mar 21.
- Hollekim-Strand SM, Hoydahl SF, Follestad T, Dalen H, Bjorgaas MR, Wisloff U, Ingul CB. Exercise Training Normalizes Timing of Left Ventricular Untwist Rate, but Not Peak Untwist Rate, in Individuals with Type 2 Diabetes and Diastolic Dysfunction: A Pilot Study. J Am Soc Echocardiogr. 2016 May;29(5):421-430.e2. doi: 10.1016/j.echo.2016.01.005. Epub 2016 Mar 3.
- Mallard AR, Hollekim-Strand SM, Ingul CB, Coombes JS. High day-to-day and diurnal variability of oxidative stress and inflammation biomarkers in people with type 2 diabetes mellitus and healthy individuals. Redox Rep. 2020 Dec;25(1):64-69. doi: 10.1080/13510002.2020.1795587.
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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