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

NCT01648985 | Completed

• 1 other identifier: catwil00
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; TIA

Outcome Measures

Primary Outcomes (1)

• Number of Stroke (fatal, non-fatal)

  Stroke is defined on clinical ground with support by CT or MR scan

  4 years

Secondary Outcomes (1)

• Number of patients with Diabetes

  4years

Other Outcomes (1)

• Number of patients with Small Vessel Disease SVD

  4 years

Study Arms (1)

Acute stroke and TIA patients

Cohort of acute stroke patients, admitted to the Stroke Unit Danderyd hospital 2010 - 2012

Other: Diabetes in stroke/TIA

Interventions

Diabetes in stroke/TIA OTHER

Mostly no intervention. A small Group of the patients recieved Yoga

Acute stroke and TIA patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Acute minor stroke and TIA patients able to perform OGTT within the first days after onset or having known diabetes.

You may not qualify if:

• Terminal disease

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Daderyd Hospital

Stockholm, S-182 88, Sweden

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 25, 2012
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2016
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

SE (1)