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- Ensayo clínico NCT01648985
Diabetes in Minor Stroke/TIA, Glucose Tolerance and Haemostasis, a Long-term-follow-up Study and Intervention With Yoga
Diabetes in Minor Stroke and TIA, Glucose Tolerance and Haemostasis, a Long-term-follow-up Study and Intervention With Yoga
In acute stroke patients about 20 % have known diabetes. There is a doubled risk of recurrent stroke in diabetic patients. It has been shown that antiplatelet drugs are not as effective in diabetic patients as in non-diabetic patients. In acute stroke patients around 80 % have impaired glucose tolerance, which will improve after one month till about 60 %.
This study includes acute patients with minor stroke or TIA. They are followed up at one and six months and then at every six months for at least four years. The investigators perform an OGTT and haemostatic tests within the first days after onset and then at one month. Blood pressure, metabolic parameters, bodyweight, physical activity and diet are collected at each visit. The investigators give the patients information about lifestyle changes as needed.
As part of the study there is an interventional study, Medicine Yoga, an open randomized controlled study. Patients are randomized to 16 sessions of Yoga under professional instructions and a CD for home training or controls.
The aims of this study are to investigate glucose tolerance in acute stroke and TIA patients, and its relation to the different haemostatic variables. The importance of glucose tolerance, haemostatic variables and other risk factors (blood pressure, lipids, BMI,) on cardiovascular events will be investigated and the possibility to affect these risk factors by lifestyle changes and Yoga. The effect of different antiplatelet drugs will be investigated in relation to glucose tolerance.
Descripción general del estudio
Descripción detallada
144 patients with minor stroke and TIA has been included in the study between 2010 and 2012. They have been follow for four years.
Two papers have been published on the results of the study. Lundström A, von Arbin M, Laska A C, Jörneskog G, Wallen NH. Glucose intolerance and insulin resistance as predictors of low platelet response to clopidogrel in patients with minor ischemic stroke or TIA. Platelets. 2013 Mar 25.341-49.
Lundström A, Wallén H, von Arbin M, Jörneskog G, Gigante B, Höeg Embrower K, Laurencikas E, Laska AC. Clopidogrel Resistance after Minor Ischemic Stroke or Transient Ischemic Attack is Associated with Radiological Cerebral Small-Vessel Disease. J Stroke Cerebrovasc Dis. 2015 Aug 21. pii: S1052-3057(15)00349-3
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Stockholm, Suecia, S-182 88
- Karolinska Institutet, Daderyd Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Acute minor stroke and TIA patients able to perform OGTT within the first days after onset or having known diabetes.
Exclusion Criteria:
- Terminal disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Acute stroke and TIA patients
Cohort of acute stroke patients, admitted to the Stroke Unit Danderyd hospital 2010 - 2012
|
Mostly no intervention.
A small Group of the patients recieved Yoga
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Stroke (fatal, non-fatal)
Periodo de tiempo: 4 years
|
Stroke is defined on clinical ground with support by CT or MR scan
|
4 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of patients with Diabetes
Periodo de tiempo: 4years
|
Diabetes is defined by HbA1c, OGTT,and fP-glucose
|
4years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of patients with Small Vessel Disease SVD
Periodo de tiempo: 4 years
|
Diagnosed through CT-scan, Fazeca scale
|
4 years
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- catwil00
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