Status:
WITHDRAWN
Oral Peri-operative TIming of Metformin (or) Salsalate to Improve Non-cardiac Surgery Glucose Control
Lead Sponsor:
McMaster University
Conditions:
Diabetes Mellitus, Type 2
Hyperglycemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Hypothesis: In surgical patients with type 2 diabetes, taking either metformin or salsalate on the morning of surgery will reduce the incidence of hyperglycemia, inflammation and even surgical site in...
Detailed Description
This internal pilot study (n=36) is designed as a 3-arm, parallel, placebo-controlled trial with block randomization. All parties will be blinded. Patient Recruitment: Patients with T2D on metformin ...
Eligibility Criteria
Inclusion
- Elective surgical patients requiring a general anesthetic at HHS requiring at least an overnight admission;
- Using metformin regularly for control of T2D;
- American Society of Anesthesiologists (ASA) physical classification I, II and III;
- Less than 1000 mL of blood loss is expected.
Exclusion
- Procedures for which non-steroidal anti-inflammatory drugs are contraindicated;
- Diagnosis of renal failure (estimated glomerular filtration rate \<60 mL/min/1.73m2);
- Liver failure;
- Previous episodes of congestive heart failure;
- Severe hypoglycemia in the past year;
- Conditions masking hypoglycemia (e.g. autonomic neuropathy);
- Low random blood glucose during pre-screening (≤4.0 mmol/L);
- Received contrast within 48h prior to, or during, surgery.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03816488
Start Date
December 1 2023
End Date
December 1 2024
Last Update
January 13 2023
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