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

NCT02729064 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2021-02-24

No results posted yet for this 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.

Conditions

  • Ischemic Heart Disease
  • Aortic Aneurysm

Interventions

DRUG

Humulin R

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

DRUG

Normal Saline

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

Sponsors & Collaborators

  • Hiroaki Sato, MD., PhD.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02729064 on ClinicalTrials.gov