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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
Information provided by (Responsible Party):
Ann Charlotte Laska, Karolinska Institutet

Brief Summary:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Acute stroke and TIA patients Other: diabetes in stroke and TIA

Primary Outcome Measures :
  1. Stroke (fatal, non-fatal) [ Time Frame: 5 years ]
    Stroke is defined on clinical ground with support by CT or MR scan

Secondary Outcome Measures :
  1. Diabetes [ Time Frame: 5 years ]
    Diabetes is defined by HbA1c, OGTT,and fP-glucose

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Acute stroke and TIA patients screened from the stroke unit at Danderyd Hospital, Stockholm, Sweden

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

Information from the National Library of Medicine

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. +46-8-12356409 ann-charlotte.laska@ds.se

Karolinska Institutet, Daderyd Hospital Recruiting
Stockholm, Sweden, S-182 88
Contact: Ann Charlotte Laska, M.D., Ph.D.    +46-8-12356409    ann-charlotte.laska@ds.se   
Sponsors and Collaborators
Karolinska Institutet

Responsible Party: Ann Charlotte Laska, M.D.,Ph.D., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01648985     History of Changes
Other Study ID Numbers: catwil00
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases