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.
調査の概要
詳細な説明
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)
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Sør-Trøndelag
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Trondheim、Sør-Trøndelag、ノルウェー、7491
- Institutt for sirkulasjon og bildediagnostikk, Det medisinske fakultet,NTNU, Postboks 8905
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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他の：. 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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他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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Early diastolic tissue velocity (e')
時間枠：3 months
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3 months
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二次結果の測定
結果測定 |
時間枠 |
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Early diastolic tissue velocity (e')
時間枠：1 year
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1 year
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協力者と研究者
捜査官
- 主任研究者：Charlotte B Ingul, PhD、NTNU, Det medisinske fakultet, Institutt for sirkulasjon og bildediagnostikk
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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