Intensive Insulin Therapy With Tight Glycemic Control to Improve Outcomes After Endovascular Therapy for Acute Ischemic Stroke

NCT02054429 | Completed Phase 1

• 1 other identifier: INSULIN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of lowering glucose (blood sugar), in addition to endovascular therapy, after acute ischemic stroke. The study will determine if lowering glucose (blood sugar) in addition to endovascular therapy will improve 90-day functional and neurological outcomes in comparison to standard glycemic care in patients with acute ischemic stroke. The study will involve treatment of 100 (50 intensive insulin therapy and 50 standard glycemic control) non-diabetic patients presenting within 8 hours of acute ischemic stroke who have undergone endovascular therapy.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Stroke Scale

  modified Rankin Score (specific aim) and NIH stroke scale (exploratory aim)

  90 days

Secondary Outcomes (1)

• MRI

  2, 3, 5, and 90 days

Study Arms (2)

Insulin

EXPERIMENTAL

IIT arm subjects will receive an insulin aspart infusion at a minimal rate of 2 units/hr while maintaining blood glucose between 90-120mg/dl for 48 hrs

Drug: Insulin

Standard glycemic control

NO INTERVENTION

standard of care if not randomized to Insulin

Interventions

Insulin DRUG

Intensive Insulin Therapy (IIT) will be given to you by two IV infusions. The insulin infusion will be started immediately after you are moved to the intensive care unit (ICU) after endovascular therapy and continued for 48 hours

Also known as: insulin and, dextrose/ potassium

Insulin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85 years
• All patients attending the emergency department (ED) of Kaleida health within 24 hrs of symptoms onset suggestive of an anterior circulation ischemic stroke.
• CT perfusion suggesting Ischemic Core less than 30% of Penumbra territory.
• No history of diabetes
• First neurological event
• The signal stroke should be (a) acute, (b) the most recent significant, acute worsening of serial neurologic events, or (c) related to a diagnostic radiographic procedure but not an interventional procedure
• Minimum NIHSS score \>4, except for isolated aphasia or isolated hemianopsia
• Angiographic evidence of a clot in the anterior intracranial or extracranial circulation consistent with the neurologic deficit with complete occlusion (TICI grade 0) or contrast penetration with minimal perfusion (TICI grade 1).
• Signed informed consent to participate given by patient or legal representative.

You may not qualify if:

• Coma
• Neurologic signs that are rapidly improving by the time of randomization or treatment- a 4-point improvement from baseline NIHSS , or increase to absolute NIHSS \> 30 before randomization or treatment
• Major stroke symptoms- NIHSS \>30
• Seizure at the onset of stroke
• Stroke due to a neurointerventional procedure for treatment of a cerebral aneurysm and/or cerebral arteriovenous malformation (stroke due to diagnostic cerebral angiography or cardiac catheterization might be treated)
• Clinical presentation suggestive of subarachnoid hemorrhage, even when the initial CT scan is normal.
• Previous known ICH at any time, neoplasm, and/or subarachnoid hemorrhage.
• Patients with a known arteriovenous malformation or aneurysm, with or without any evidence of associated hemorrhage.
• Presumed septic embolus
• Known hereditary or acquired hemorrhagic diathesis, eg, aPTT or prothrombin time greater than normal; unsupported coagulation factor deficiency.
• Baseline laboratory values that reveal platelets are \<30 000/µL, hematocrit or platelet cell volume \<25 volume %, or international normalized ratio \>1.7. (Any patient receiving heparin at the onset of stroke symptoms must have an aPTT 2 times the upper limit of normal before randomization. Patients receiving low-molecular-weight heparin might need to be excluded because an anticoagulant effect is not measured by aPTT.)
• Pregnancy, lactation, or parturition within the previous 30 days.
• Known serious sensitivity to radiographic contrast agents.
• Other serious, advanced, or terminal illness such that life expectancy is \<1 year.
• Current participation in another research treatment protocol.

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

University of Buffalo Neurosurgery

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Insulin; Glucose; Potassium

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Hexoses; Monosaccharides; Sugars; Carbohydrates; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chairman & Associate Professor

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: January 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (1)