Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01648985
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : September 3, 2018
Sponsor:
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/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


Layout table for study information
Study Type : Observational
Actual Enrollment : 144 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
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2016

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




Primary Outcome Measures :
  1. Number of Stroke (fatal, non-fatal) [ Time Frame: 4 years ]
    Stroke is defined on clinical ground with support by CT or MR scan


Secondary Outcome Measures :
  1. Number of patients with Diabetes [ Time Frame: 4years ]
    Diabetes is defined by HbA1c, OGTT,and fP-glucose


Other Outcome Measures:
  1. Number of patients with Small Vessel Disease SVD [ Time Frame: 4 years ]
    Diagnosed through CT-scan, Fazeca scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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
Criteria

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


Locations
Layout table for location information
Sweden
Karolinska Institutet, Daderyd Hospital
Stockholm, Sweden, S-182 88
Sponsors and Collaborators
Karolinska Institutet

Layout table for additonal information
Responsible Party: Ann Charlotte Laska, Principal Investigator, 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: September 3, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hemostatics
Coagulants