The Impact of Maltodextrin on Insulin Sensitivity in Diabetic Patients Undergoing Cardiac Surgery
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 |
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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
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:
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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:
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Outcome Measures
Primary Outcome Measures
- 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
- Insulin sensitivity [1 hour after infusion]
Glucose infusion rate after 1 hour of the hyperinsulinemic-euglycemic clamp
- Vasopressor requirements [Arrival to the ICU]
Dose of vasopressors upon arrival to the ICU
- Glucose levels [48 hours after surgery]
Glucose levels measured postoperatively
- Time to extubation [First 24 hours after surgery]
Time from ICU arrival to extubation
- Length of ICU stay [First 1-7 days after surgery]
Time from surgery to ICU discharge
- Hospital Length of Stay [1-4 weeks after surgery]
Time from surgery to discharge from the hospital
- 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
Inclusion Criteria:
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18 years of age or older
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Presenting for cardiac surgery
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Diagnosis of diabetes mellitus type 2 or a hemoglobin A1c value >6%.
Exclusion Criteria:
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Dysphagia, gastroparesis
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Cannot tolerate oral intake,
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Celiac disease,
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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.- MP-05-2022-3112