Brain IschemiaGLIAS-IIINCT04001049
Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke
An observational study of Brain Ischemia and Hyperglycemia, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Ischemia, Hyperglycemia, Glycemic Variability
- How many people
- 192 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2020to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients > 18 years old presenting with acute ischemic stroke of less than 24 hours of evolution
Who may be able to join
- > 18 years old
- Functional independence prior to stroke
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Ischemia, Hyperglycemia, Glycemic Variability
- Medical subject headings
- Brain Ischemia, Hyperglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic variation impact in mortality of patients with acute ischemic stroke
Intrahospital mortality
Measured: 3 months from stroke
Glycemic variation impact in functional status of patients with acute ischemic 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
Measured: 3 months from stroke
Secondary outcomes (2)
Impact of glycemic variation in mortality in diabetic patients with acute ischemic stroke.
Intrahospital mortality
Measured: 3 months from stroke
Impact of glycemic variation in functional status in diabetic patients with acute ischemic 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
Measured: 3 months from stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start30 Jun 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blanca Fuentes Gimeno, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001049
- Sponsor's protocol ID
- GLIAS-III
- Acronym
- GLIAS-III
- Status last verified
- May 2026
- First submitted
- 22 May 2019
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33148277
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke and Impact of the Corrective Treatment for Hyperglycemia.
- ClinicalTrials.gov ID
- NCT04001049
- Acronym / sponsor ID
- GLIAS-III / GLIAS-III
- Conditions
- Brain Ischemia, Hyperglycemia, Glycemic Variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients > 18 years old presenting with acute ischemic stroke of less than 24 hours of evolution
Key inclusion criteria (3 listed)
- > 18 years old
- Functional independence prior to stroke
- Signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glycemic variation impact in mortality of patients with acute ischemic stroke
Time frame: 3 months from stroke
Intrahospital mortality
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
2 secondary outcomes
Impact of glycemic variation in mortality in diabetic patients with acute ischemic stroke.
Time frame: 3 months from stroke
Impact of glycemic variation in functional status in diabetic patients with acute ischemic stroke.
Time frame: 3 months from stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 33148277Fuentes 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blanca Fuentes Gimeno principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Ischemia and Hyperglycemia, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic variation impact in mortality of patients with acute ischemic stroke (time frame: 3 months from stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.