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.
Descripción general del estudio
Descripción detallada
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)
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sør-Trøndelag
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Trondheim, Sør-Trøndelag, Noruega, 7491
- Institutt for sirkulasjon og bildediagnostikk, Det medisinske fakultet,NTNU, Postboks 8905
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: . 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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Otro: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Early diastolic tissue velocity (e')
Periodo de tiempo: 3 months
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Early diastolic tissue velocity (e')
Periodo de tiempo: 1 year
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Charlotte B Ingul, PhD, NTNU, Det medisinske fakultet, Institutt for sirkulasjon og bildediagnostikk
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 4.2009.365
Información sobre medicamentos y dispositivos, documentos del estudio
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