Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke (GLIAS-III)

July 6, 2020 updated by: Instituto de Investigación Hospital Universitario La Paz

Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke and Impact of the Corrective Treatment for Hyperglycemia.

This is a multicenter observational clinical study in patients with acute ischemic stroke. The main objective is to evaluate the impact of glycemic variability (GV) on stroke outcome (mortality, functional recovery) of patients with acute ischemic stroke. Glycemic variability will be assessed using a subcutaneous device for continuous glycaemia motorization during 96 hours; also capillar glycaemia will be measured every 6 hours.

Study Overview

Status

Unknown

Conditions

Detailed Description

10 different hospitals in Spain will participate in this study, recruiting a total of 340 patients. Once the informed consent form is signed, the subcutaneous device for continuous glycaemia motorization will be implanted and demographic, comorbidities and treatments of every patient will be registered. During the first 96 hours, capillar glycaemia, NIHSS scale, HbA1C levels, cerebral recanalization treatment and glycaemia correcting treatments will also be reported. In the following days (7, 30 and 90 days after stroke) modified Rankin Scale, NIHSS scale and stroke secondary prevention treatments will be evaluated. At day 90, a new measure of HbA1C will be done.

Study Type

Observational

Enrollment (Anticipated)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients > 18 years old presenting with acute ischemic stroke of less than 24 hours of evolution

Description

Inclusion Criteria:

  • > 18 years old
  • Inclusion less than 24 hours from ischemic stroke
  • Functional independence prior to stroke
  • Signed informed consent

Exclusion Criteria:

  • Transient cerebral ischemia
  • Prevision of need to perform a magnetic resonance within the first 96 hours from inclusion
  • Concomitant severe or deadly disease that may interfere with study follow-up during 3 months from stroke
  • Current drug or alcohol abuse that may interfere with study follow-up
  • Participation in a clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic variation impact in mortality of patients with acute ischemic stroke
Time Frame: 3 months from stroke
Intrahospital mortality
3 months from stroke
Glycemic variation impact in functional status of patients with acute ischemic stroke
Time Frame: 3 months from stroke

Modified Rankin Scale. This scale measures degree of disability/dependence after a stroke.

0- No symptoms

  1. No significant disability despite symptoms; able to perform all usual duties and activities.
  2. Slight disability; unable to perform all previous activities but able to look after own affairs without assistance.
  3. Moderate disability; requires some help but able to walk without assistance.
  4. Moderate severe disability; unable to walk without assistance an unable to attend to own bodily needs without assistance
  5. Severe disability; bedridden, incontinent and requires constant nursing care and attention.
  6. Death
3 months from stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of glycemic variation in mortality in diabetic patients with acute ischemic stroke.
Time Frame: 3 months from stroke
Intrahospital mortality
3 months from stroke
Impact of glycemic variation in functional status in diabetic patients with acute ischemic stroke.
Time Frame: 3 months from stroke

Modified Rankin Scale. This scale measures degree of disability/dependence after a stroke.

0- No symptoms

  1. No significant disability despite symptoms; able to perform all usual duties and activities.
  2. Slight disability; unable to perform all previous activities but able to look after own affairs without assistance.
  3. Moderate disability; requires some help but able to walk without assistance.
  4. Moderate severe disability; unable to walk without assistance an unable to attend to own bodily needs without assistance
  5. Severe disability; bedridden, incontinent and requires constant nursing care and attention.
  6. Death
3 months from stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Investigators

  • Principal Investigator: Blanca Fuentes Gimeno, Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 27, 2019

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLIAS-III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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