NCT02571608

Continuation of Metformin to Improve And Keep Peri-operative Glycemic Control

ContinuAtioN of meTformin to Improve And KEep Peri-operative Glycemic Control: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Type II Diabetes Mellitus patients having surgery who adhere to their regular scheduled metformin dosing and take this medication on the morning of surgery will have better glycemic control peri-operatively and potentially suffer less morbidity compared to individuals taking a placebo.

Detailed description

Peri-operative hyperglycemia has been linked to numerous negative adverse consequences, including wound infection, impaired wound healing, endothelial dysfunction, neurocognitive dysfunction, sepsis, prolonged hospital stay and increased mortality. This has been shown in numerous studies as outlined in our detailed research proposal. The peri-operative period includes a timeframe ranging from 12 to 72 hours around the time of surgery according to definition. Our study is examining glycemic control in the peri-operative period which we are defining as approximately 48 hours around the time of surgery. The majority of the patients with type II diabetes take oral medications, such as metformin, to control their blood sugar. These patients have historically held their doses on the day of the surgery to avoid possible low blood sugar and lactic acidosis while fasting. However, numerous recent studies have shown that individuals who are fasting without renal, heart and liver failure are safe to take metformin. The most recent guidelines from the American diabetes association suggest that patients should take their dose of metformin on the day of surgery. Despite these recommendations most anesthesiologists continue to withhold metformin on the day of surgery, as no studies exist to show the benefit of continuing metformin. If we are able to show that patients taken metformin have better glycemic control during this time we can extrapolate that result mean they may have a lower incidence of the consequences linked to poor glycemic control.

Conditions

• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
DRUG	Metformin	The study intervention involves Type II Diabetes Mellitus patient self-administered metformin vs. placebo according to regular dosing schedule and randomization. Both placebo and active drug will be over-encapsulated by pharmacy so that they will be indistinguishable to the personnel involved in the study.
DRUG	Placebo	The study intervention involves Type II Diabetes Mellitus patient self-administered metformin vs. placebo according to regular dosing schedule and randomization. Both placebo and active drug will be over-encapsulated by pharmacy so that they will be indistinguishable to the personnel involved in the study.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2015-10-08
• Last updated: 2021-10-08