Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke

NCT ID: NCT04001049

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Ischemia Hyperglycemia Glycemic Variability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Blanca Fuentes Gimeno

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Locations

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Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Blanca Fuentes Gimeno

Role: CONTACT

+34917277444

Elena de Celis Ruiz

Role: CONTACT

+34917277444

Facility Contacts

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Silvia Pastor Yvorra

Role: primary

917277444

Blanca Fuentes Gimeno

Role: backup

917277444

References

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Fuentes B, Pastor-Yborra S, Gutierrez-Zuniga R, Gonzalez-Perez de Villar N, de Celis E, Rodriguez-Pardo J, Gomez-de Frutos MC, Laso-Garcia F, Gutierrez-Fernandez M, Ortega-Casarrubios M, Soto A, Lopez-Fernandez M, Santamaria M, Diez-Gonzalez N, Freijo MM, Zandio B, Delgado-Mederos R, Calleja A, Portilla-Cuenca JC, Lisbona A, Otero-Ortega L, Diez-Tejedor E. Glycemic variability: prognostic impact on acute ischemic stroke and the impact of corrective treatment for hyperglycemia. The GLIAS-III translational study. J Transl Med. 2020 Nov 4;18(1):414. doi: 10.1186/s12967-020-02586-4.

Reference Type DERIVED
PMID: 33148277 (View on PubMed)

Other Identifiers

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GLIAS-III

Identifier Type: -

Identifier Source: org_study_id

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