Diabetes in Minor Stroke and TIA, Glucose Tolerance and Haemostasis, a Long-term-follow-up Study and Intervention With Yoga
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|ClinicalTrials.gov Identifier: NCT01648985|
Recruitment Status : Recruiting
First Posted : July 25, 2012
Last Update Posted : August 23, 2012
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.
|Condition or disease||Intervention/treatment|
|Stroke TIA||Other: diabetes in stroke and TIA|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Diabetes in Minor Stroke and TIA, Glucose Tolerance and Haemostasis, a Long-term-follow-up Study and Intervention With Yoga|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2018|
|Acute stroke and TIA patients||Other: diabetes in stroke and TIA|
- Stroke (fatal, non-fatal) [ Time Frame: 5 years ]Stroke is defined on clinical ground with support by CT or MR scan
- Diabetes [ Time Frame: 5 years ]Diabetes is defined by HbA1c, OGTT,and fP-glucose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648985
|Contact: Ann Charlotte Laska, M.D.,Ph.D.||+email@example.com|
|Karolinska Institutet, Daderyd Hospital||Recruiting|
|Stockholm, Sweden, S-182 88|
|Contact: Ann Charlotte Laska, M.D., Ph.D. +46-8-12356409 firstname.lastname@example.org|