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.

Study Overview

• Status: Completed
• Conditions: Stroke; TIA
• Intervention / Treatment: Other: Diabetes in stroke/TIA

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, S-182 88
    • Karolinska Institutet, Daderyd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Acute stroke and TIA patients screened from the stroke unit at Danderyd Hospital, Stockholm, Sweden

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute stroke and TIA patients; Cohort of acute stroke patients, admitted to the Stroke Unit Danderyd hospital 2010 - 2012	Other: Diabetes in stroke/TIA; Mostly no intervention. A small Group of the patients recieved Yoga

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Stroke (fatal, non-fatal)	Stroke is defined on clinical ground with support by CT or MR scan	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Diabetes	Diabetes is defined by HbA1c, OGTT,and fP-glucose	4years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Small Vessel Disease SVD	Diagnosed through CT-scan, Fazeca scale	4 years

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 31, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: catwil00