Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose

NCT02729064 | Unknown Phase 1

• 1 other identifier: 5381
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Blood Glucose

  Arterial blood samples will be collected every 10 to 30 minutes during the surgery. Circulating concentrations of glucose will be measured.

  During Surgery

• Plasma Insulin

  Arterial blood samples will be collected every 10 to 30 minutes during the surgery. Plasma insulin will be measured.

  During Surgery

• Cerebrospinal Fluid Insulin

  Cerebrospinal Fluid will be taken every 10 to 30 minutes during the endovascular thoracic aneurysm repair surgery. Insuring concentration of Cerebrospinal fluid will be measured.

  During Surgery

Study Arms (3)

Intranasal 40

EXPERIMENTAL

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

Drug: Humulin R

Intranasal 80

EXPERIMENTAL

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

Drug: Humulin R

Placebo

PLACEBO COMPARATOR

Patients will receive intranasal normal saline via a metered nasal dispenser

Drug: Normal Saline

Interventions

Humulin R DRUG

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

Intranasal 40; Intranasal 80

Normal Saline DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hiroaki Sato, MD., PhD.: lead

Study Sites (1)

Royal Victoria Hospital McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (2)

• Roque P, Nakadate Y, Sato H, Sato T, Wykes L, Kawakami A, Yokomichi H, Matsukawa T, Schricker T. Intranasal administration of 40 and 80 units of insulin does not cause hypoglycemia during cardiac surgery: a randomized controlled trial. Can J Anaesth. 2021 Jul;68(7):991-999. doi: 10.1007/s12630-021-01969-5. Epub 2021 Mar 15.

  PMID: 33721199 DERIVED

• Nakadate Y, Sato H, Roque P, Sato T, Matsukawa T, Wykes L, Kawakami A, Schricker T. Accuracy of blood glucose measurements using the NOVA StatStrip(R) glucometer during cardiac surgery: a prospective observational study. Can J Anaesth. 2019 Aug;66(8):943-952. doi: 10.1007/s12630-019-01350-7. Epub 2019 Mar 20.

  PMID: 30895515 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia; Aortic Aneurysm

Interventions

Insulin; Saline Solution

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Hiroaki Sato, MD., PhD.

CONTACT

+15149341934; hiroaki.sato2@mcgill.ca

Thomas Schricker, MD., PhD.

CONTACT

+15149341934; thomas.schricker@mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 6, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)