Diabetes in Minor Stroke/TIA, Glucose Tolerance and Haemostasis, a Long-term-follow-up Study and Intervention With Yoga

Stroke Clinical Trial

Official title:

Diabetes in Minor Stroke and TIA, Glucose Tolerance and Haemostasis, a Long-term-follow-up Study and Intervention With Yoga

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648985
• Other study ID #: catwil00
• Status: Completed
• Start date: May 2010
• Est. completion date: November 2016

Study information

• Verified date: August 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: November 2016
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• TIA

Intervention

Other:
• Diabetes in stroke/TIA
Mostly no intervention. A small Group of the patients recieved Yoga

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Daderyd Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with Small Vessel Disease SVD	Diagnosed through CT-scan, Fazeca scale	4 years
Primary	Number of Stroke (fatal, non-fatal)	Stroke is defined on clinical ground with support by CT or MR scan	4 years
Secondary	Number of patients with Diabetes	Diabetes is defined by HbA1c, OGTT,and fP-glucose	4years