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Completed

NCT Number: NCT04001049

Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke

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.

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Key information

Conditions

Brain Ischemia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Glucose Metabolism Disorders Glycemic Variability Hyperglycemia Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario La Paz

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Glycemic variation impact in mortality of patients with acute ischemic stroke

    Time frame: 3 months from stroke

    Intrahospital mortality

  2. 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

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

Secondary outcomes

  1. Impact of glycemic variation in mortality in diabetic patients with acute ischemic stroke.

    Time frame: 3 months from stroke

    Intrahospital mortality

  2. 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

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

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study title

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

Acronym: GLIAS-III

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2019
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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