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

Effect of Intranasal Insulin Administration on Glycaemia and Insulin Concentrations in Plasma and Cerebrospinal Fluid During Surgery

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02729064
Enrollment
141
Registered
2016-04-06
Start date
2016-09-30
Completion date
2021-09-30
Last updated
2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease, Aortic Aneurysm

Keywords

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

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.

Detailed description

Clinical trials have demonstrated that intranasal insulin improves both memory performance and metabolic integrity of the brain in patients suffering from Alzheimer's disease or cognitive impairment. A single dose of intranasal insulin acutely improved memory in memory-impaired older adults. Cognitive impairment in post-operative period is an increasing problem as more elderly patients undergo major surgery. The investigators have previously shown that intraoperative insulin administration while maintaining normoglycaemia preserves both short and long-term memory function after open heart surgery. 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.

Interventions

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

DRUGNormal Saline

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

Sponsors

Hiroaki Sato, MD., PhD.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood GlucoseDuring SurgeryArterial blood samples will be collected every 10 to 30 minutes during the surgery. Circulating concentrations of glucose will be measured.
Plasma InsulinDuring SurgeryArterial blood samples will be collected every 10 to 30 minutes during the surgery. Plasma insulin will be measured.
Cerebrospinal Fluid InsulinDuring SurgeryCerebrospinal Fluid will be taken every 10 to 30 minutes during the endovascular thoracic aneurysm repair surgery. Insuring concentration of Cerebrospinal fluid will be measured.

Countries

Canada

Contacts

Primary ContactHiroaki Sato, MD., PhD.
hiroaki.sato2@mcgill.ca+15149341934
Backup ContactThomas Schricker, MD., PhD.
thomas.schricker@mcgill.ca+15149341934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026