Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729064
Recruitment Status : Recruiting
First Posted : April 6, 2016
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Hiroaki Sato, MD., PhD., McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Aortic Aneurysm Drug: Humulin R Drug: Normal Saline Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Intranasal Insulin Administration on Glycaemia and Insulin Concentrations in Plasma and Cerebrospinal Fluid During Surgery
Actual Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: Intranasal 40
Patients will receive 40 IU of intranasal insulin (Humulin R) via a metered nasal dispenser
Drug: Humulin R
Study subjects will receive 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
Drug: Humulin R
Study subjects will receive intranasal insulin (Humulin R) via a metered nasal dispenser.

Placebo Comparator: Placebo
Patients will receive intranasal normal saline via a metered nasal dispenser
Drug: Normal Saline
Study subjects will receive intranasal placebo (normal saline) via a metered nasal dispenser.




Primary Outcome Measures :
  1. Blood Glucose [ Time Frame: During Surgery ]
    Arterial blood samples will be collected every 10 to 30 minutes during the surgery. Circulating concentrations of glucose will be measured.

  2. Plasma Insulin [ Time Frame: During Surgery ]
    Arterial blood samples will be collected every 10 to 30 minutes during the surgery. Plasma insulin will be measured.

  3. Cerebrospinal Fluid Insulin [ Time Frame: During Surgery ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729064


Contacts
Layout table for location contacts
Contact: Hiroaki Sato, MD., PhD. +15149341934 ext 36717 hiroaki.sato2@mcgill.ca
Contact: Thomas Schricker, MD., PhD. +15149341934 ext 34883 thomas.schricker@mcgill.ca

Locations
Layout table for location information
Canada, Quebec
Royal Victoria Hospital McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Hiroaki Sato, MD., PhD.    5149341934 ext 36717    hiroaki.sato2@mcgill.ca   
Sponsors and Collaborators
Hiroaki Sato, MD., PhD.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hiroaki Sato, MD., PhD., Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02729064    
Other Study ID Numbers: 5381
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hiroaki Sato, MD., PhD., McGill University Health Centre/Research Institute of the McGill University Health Centre:
Intranasal Insulin
Insulin concentration
Blood glucose
Cerebro Spinal Fluid insulin
Intraoperative blood glucose
Cardiac Surgery
Thoracic Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Aneurysm
Aortic Aneurysm
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Aortic Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs