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Insulin

Intranasal 40 for Aortic Aneurysm

Phase 1
Waitlist Available
Research Sponsored by Hiroaki Sato, MD., PhD.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients (>18 years) undergoing elective open heart surgery requiring CPB or elective endovascular thoracic aortic aneurysm repair at the RVH.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during surgery
Awards & highlights

Study Summary

Intranasal insulin is reported to improves memory performance in patients suffering from cognitive impairment. The investigators have previously shown that intraoperative insulin administration preserves both short and long-term memory function after cardiac surgery. Applying intranasal insulin bypasses blood-brain barrier and cause elevation of insulin concentrations in the cerebrospinal fluid without major effects on peripheral insulin level. Patients undergoing major surgery are exposed to carbohydrate and insulin metabolism alteration. The goal of the study is to study the effect of intranasal insulin on blood glucose, plasma and cerebrospinal insulin concentration in patients undergoing cardiac surgery or endovascular thoracic aneurysm repair.

Eligible Conditions
  • Aortic Aneurysm
  • Coronary Artery Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and during surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Glucose
Cerebrospinal Fluid Insulin
Plasma Insulin

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Intranasal 80Experimental Treatment1 Intervention
Patients will receive 80 IU of intranasal insulin (Humulin R) via a metered nasal dispenser
Group II: Intranasal 40Experimental Treatment1 Intervention
Patients will receive 40 IU of intranasal insulin (Humulin R) via a metered nasal dispenser
Group III: PlaceboPlacebo Group1 Intervention
Patients will receive intranasal normal saline via a metered nasal dispenser
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin human
FDA approved

Find a Location

Who is running the clinical trial?

Hiroaki Sato, MD., PhD.Lead Sponsor
1 Previous Clinical Trials
494 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~16 spots leftby Apr 2025