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The Impact of Maltodextrin on Insulin Sensitivity in Diabetic Patients Undergoing Cardiac Surgery

Sponsor
Jewish General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05188222
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A randomized, controlled trial evaluating the effect of the administration of a Maltodextrin solution in type 2 diabetic patients undergoing cardiac surgery.

Condition or Disease Intervention/Treatment Phase
  • Drug: Maltodextrin solution
  • Drug: Water solution
 Phase 4

Detailed Description

This is a randomized, controlled, feasibility trial. The primary objective is to evaluate the feasibility of having patients receive the preoperative drink within 2 to 3 hours before induction of anesthesia and consume the entire solution within the suggested 15 minutes.

The secondary objective is to compare insulin sensitivity in type 2 diabetic cardiac surgery patients who received maltodextrin before surgery versus type 2 diabetic patients who have only received water. The hyperinsulinemic-euglycemic insulin clamp will be performed just after the induction of anesthesia to measure insulin sensitivity.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be assigned to the intervention or control group based on a computer-generated 1:1 block randomization by procedure type in blocks of 1. The types of procedures used for block randomization will be defined as coronary artery bypass graft (CABG)-only, valve-only, or combined cardiac surgery.Patients will be assigned to the intervention or control group based on a computer-generated 1:1 block randomization by procedure type in blocks of 1. The types of procedures used for block randomization will be defined as coronary artery bypass graft (CABG)-only, valve-only, or combined cardiac surgery.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Appropriate Administration of a Preoperative Maltodextrin Solution in Diabetic Patients Undergoing Cardiac Surgery: A Randomized Controlled Feasibility Trial
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Patients in the intervention group will receive an oral preparation of 50 grams of Maltodextrin solution mixed in 400 millilitres (mL) of water within 2-3 hours before surgery. The entire drink is meant to be consumed within 15 minutes.

Drug: Maltodextrin solution
The oral preparation of 50 grams of Maltodextrin solution mixed in 400 mL of water
Other Names:
  • Intervention group

    		•
    Placebo Comparator: Control group

    Patients will drink 400 mL of water for 15 mins, within 2-3 hours prior to surgery.

    Drug: Water solution
    Glass of 400 mL of water
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of patients having the preoperative drink within appropriate time frame [2 to 3 hours from the induction of anesthesia]

      The time from which the patient began drinking the solution to induction of anesthesia will be noted, along with whether the patient was able to consume the entire drink within 15 minutes

    Secondary Outcome Measures

    1. Insulin sensitivity [1 hour after infusion]

      Glucose infusion rate after 1 hour of the hyperinsulinemic-euglycemic clamp

    2. Vasopressor requirements [Arrival to the ICU]

      Dose of vasopressors upon arrival to the ICU

    3. Glucose levels [48 hours after surgery]

      Glucose levels measured postoperatively

    4. Time to extubation [First 24 hours after surgery]

      Time from ICU arrival to extubation

    5. Length of ICU stay [First 1-7 days after surgery]

      Time from surgery to ICU discharge

    6. Hospital Length of Stay [1-4 weeks after surgery]

      Time from surgery to discharge from the hospital

    7. Postoperative complications [1-4 weeks after surgery]

      as death, need for intra aortic balloon pump, dialysis, stroke, positive bacterial culture from the wound or blood

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years of age or older

    • Presenting for cardiac surgery

    • Diagnosis of diabetes mellitus type 2 or a hemoglobin A1c value >6%.

    Exclusion Criteria:

    • Dysphagia, gastroparesis

    • Cannot tolerate oral intake,

    • Celiac disease,

    • Type 1 diabetes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jewish General Hospital Montreal Quebec Canada H3T1E2

    Sponsors and Collaborators

    • Jewish General Hospital

    Investigators

    • Principal Investigator: Matthew Cameron, MDCM, MPH, McGill University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matthew Cameron, Assistant Professor, Jewish General Hospital
    ClinicalTrials.gov Identifier:
    NCT05188222
    Other Study ID Numbers:
    • MP-05-2022-3112
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    May 3, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Matthew Cameron, Assistant Professor, Jewish General Hospital
    Cardiac surgery
    Insulin
    Maltodextrin
    Additional relevant MeSH terms:
    Insulin Resistance
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of May 3, 2022