Diabetes in Minor Stroke and TIA, Glucose Tolerance and Haemostasis, a Long-term-follow-up Study and Intervention With Yoga
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Purpose
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 | Intervention |
|---|---|
|
Stroke TIA |
Other: diabetes in stroke and TIA |
| Study Type: | Observational |
| Study Design: | 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 |
- Stroke (fatal, non-fatal) [ Time Frame: 5 years ] [ Designated as safety issue: No ]Stroke is defined on clinical ground with support by CT or MR scan
- Diabetes [ Time Frame: 5 years ] [ Designated as safety issue: No ]Diabetes is defined by HbA1c, OGTT,and fP-glucose
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Acute stroke and TIA patients | Other: diabetes in stroke and TIA |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
Contacts and Locations| Contact: Ann Charlotte Laska, M.D.,Ph.D. | +46-8-12356409 | ann-charlotte.laska@ds.se |
| Sweden | |
| 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 | |
More Information
No publications provided
| Responsible Party: | Ann Charlotte Laska, M.D.,Ph.D., Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT01648985 History of Changes |
| Other Study ID Numbers: | catwil00 |
| Study First Received: | July 18, 2012 |
| Last Updated: | August 22, 2012 |
| Health Authority: | Sweden: Goverment Health |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Brain Infarction Brain Ischemia Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013