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Could waiting to lower blood sugar after severe stroke improve outcomes?

NCT ID NCT07501533

Disease control Sponsor: First Affiliated Hospital of Wannan Medical College Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study looks at whether starting insulin to lower high blood sugar on day 4 after a severe stroke is better than starting on day 1. About 200 adults with severe stroke and high blood sugar will be randomly assigned to early or delayed treatment. The goal is to see if delaying treatment leads to better neurological function and fewer deaths at 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intravenous insulin
What this could lead to
If it works, this could show that waiting a few days to lower blood sugar after a severe stroke leads to better recovery.
What could go wrong
This is an early phase 2 trial with only 200 participants, so results may not apply broadly. There is also a risk of hypoglycemia or infections from insulin therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years; 2. Severe stroke within 24 hours of onset, meeting one of the following criteria: 1）Severe ischemic stroke: Glasgow Coma Scale (GCS) score ≤ 12 or National Institutes of Health Stroke Scale (NIHSS) score ≥ 15 or CT hypodensity \> 1/3 of middle cerebral artery (MCA) territory; 2）Severe intracerebral hemorrhage: Supratentorial hematoma volume ≥ 30 mL (thalamic hemorrhage ≥ 10 mL) or infratentorial hematoma volume ≥ 10 mL (brainstem hemorrhage ≥ 5 mL); 3）Aneurysmal subarachnoid hemorrhage; 3. Blood glucose level \> 10 mmol/L at randomization; 4. Signed informed consent. Exclusion Criteria: 1. Known history of type 1 diabetes mellitus; 2. Known allergy to insulin or diagnosis of insulinoma; 3. Pre-stroke modified Rankin Scale (mRS) score \> 1; 4. Hemodynamic instability refractory to medical treatment (systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg); 5. Decompensated heart failure (New York Heart Association \[NYHA\] class III or IV); 6. Estimated glomerular filtration rate (eGFR) \< 30 mL/min; 7. Expected survival \< 90 days due to malignancy; 8. Participation in another drug or device clinical trial within the past 30 days; 9. Women of childbearing potential who refuse to use effective contraception despite negative pregnancy test, pregnant women, or breastfeeding women.

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Conditions

The condition(s) this trial relates to.

acquired aneurysmal subarachnoid hemorrhage intracerebral hemorrhage ischemic stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)

    RECRUITING

    Wuhu, Anhui, 241001, China

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