Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose
NCT ID: NCT02729064
Last Updated: 2021-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
141 participants
INTERVENTIONAL
2016-09-30
2021-09-30
Brief Summary
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Detailed Description
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Applying insulin as a nasal spray bypasses blood-brain barrier and cause significant and sustained elevation of insulin concentrations in the cerebrospinal fluid (CSF) without major effects on peripheral insulin levels. The administration of 40 IU of intranasal insulin(INI) rapidly increases CSF insulin concentration within seven minutes, peaking after 30 minutes and remaining elevated for more than 80 minutes.
Presently it is not clear if CNS insulin plays a relevant role in controlling blood glucose in humans.
Patients undergoing major surgery are exposed to metabolic and endocrine alterations in carbohydrate, protein, and insulin metabolism, often summarized as the catabolic stress response. While the effect of intravenous insulin on glucose metabolism during surgery has been extensively studied the influence of intranasal insulin administration on intraoperative plasma insulin and blood glucose concentrations is unknown.
Goal and Objectives The goal of the present study is to study the effect of intranasal insulin on
* blood glucose and plasma insulin concentrations in patients undergoing elective cardiac surgery
* blood glucose, plasma insulin and cerebrospinal insulin concentration in patients undergoing elective endovascular thoracic aneurysm repair.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Intranasal 40
Patients will receive 40 IU of intranasal insulin (Humulin R) via a metered nasal dispenser
Humulin R
Study subjects will receive intranasal insulin (Humulin R) via a metered nasal dispenser.
Intranasal 80
Patients will receive 80 IU of intranasal insulin (Humulin R) via a metered nasal dispenser
Humulin R
Study subjects will receive intranasal insulin (Humulin R) via a metered nasal dispenser.
Placebo
Patients will receive intranasal normal saline via a metered nasal dispenser
Normal Saline
Study subjects will receive intranasal placebo (normal saline) via a metered nasal dispenser.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patients with allergy to insulin
3. Patients with a base line blood glucose less than 3.9 mmol/L
18 Years
ALL
No
Sponsors
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Hiroaki Sato, MD., PhD.
OTHER
Responsible Party
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Hiroaki Sato, MD., PhD.
Assistant Professor
Locations
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Royal Victoria Hospital McGill University Health Centre
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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5381
Identifier Type: -
Identifier Source: org_study_id
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