Recruiting
Phase 1

Nasal Insulin

Sponsor:

Hiroaki Sato, MD., PhD.

Code:

NCT02729064

Conditions

Ischemic Heart Disease

Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Humulin R

Normal Saline

Study Details

Brief 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.

Conditions

Ischemic Heart Disease

Aortic Aneurysm

Study ID

NCT02729064

Start date

Sep, 2016

Status verified date

Feb, 2021

Completion date

Sep, 2021

Anticipated

Primary completion date

Sep, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

All patients (>18 years) undergoing elective open heart surgery requiring CPB or elective endovascular thoracic aortic aneurysm repair at the RVH.

Exclusion Criteria:

1. Planned use of drugs that effect plasma glucose concentration during the first four hours of surgery.
2. Patients with allergy to insulin
3. Patients with a base line blood glucose less than 3.9 mmol/L

Study Design

Enrollment

141 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Intranasal 40

Patients will receive 40 IU of intranasal insulin (Humulin R) via a metered nasal dispenser

experimental: Intranasal 80

Patients will receive 80 IU of intranasal insulin (Humulin R) via a metered nasal dispenser

placebo comparator: Placebo

Patients will receive intranasal normal saline via a metered nasal dispenser

Interventions

Humulin R

Study subjects will receive intranasal insulin (Humulin R) via a metered nasal dispenser.

Normal Saline

Study subjects will receive intranasal placebo (normal saline) via a metered nasal dispenser.

Primary outcome measure

  • Blood Glucose [ Time Frame: During Surgery ]
  • Plasma Insulin [ Time Frame: During Surgery ]
  • Cerebrospinal Fluid Insulin [ Time Frame: During Surgery ]

Central Contacts and Locations

Central contacts

Thomas Schricker, MD., PhD.

+15149341934thomas.schricker@mcgill.ca

Locations

Royal Victoria Hospital McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Hiroaki Sato, MD., PhD.

5149341934hiroaki.sato2@mcgill.ca

More Information

Sponsor

Hiroaki Sato, MD., PhD.

Last update posted

Feb 24, 2021

Last verified

Feb, 2021

Keywords

  • Intranasal Insulin
  • Insulin concentration
  • Blood glucose
  • Cerebro Spinal Fluid insulin
  • Intraoperative blood glucose
  • Cardiac Surgery
  • Thoracic Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hiroaki Sato, MD., PhD. on 2021-02-24.