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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Ann Charlotte Laska, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01648985
First received: July 18, 2012
Last updated: August 22, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648985

Contacts
Contact: Ann Charlotte Laska, M.D.,Ph.D. +46-8-12356409 ann-charlotte.laska@ds.se

Locations
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   
Sponsors and Collaborators
Karolinska Institutet
  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:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014