Oral Peri-operative TIming of Metformin (or) Salsalate to Improve Non-cardiac Surgery Glucose Control
Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
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 infections, without any obvious patient risk relative to patients given a
placebo control.
Anesthesia and surgery induce a number of metabolic disturbances, particularly among patients
with type 2 diabetes (T2D). This includes altered glucose metabolism and hyperglycemia, which
is associated with significant morbidity and mortality, including an increase in surgical
site infections (SSI). Although insulin protocols can reduce blood glucose levels in
hyperglycemic surgical patients, leading to reduced SSI, this has caused severe hypoglycemia
in a number of patients. Instead, the use of simple and effective interventions, such as
continuing metformin on the day of surgery, could represent an important step toward reducing
the incidence of these morbid outcomes while improving glucose control. Alternatively,
salsalate, a non-acetylated dimer of salicylic acid, has also emerged as a novel
glucose-lowering medication that also possesses important anti-pyretic and anti-inflammatory
properties and could prove equally effective.These refinements may also reduce SSI and
inflammation. If the proposed pilot trial, to continue metformin, or take salsalate,
peri-operatively, is as safe and easy as the investigators anticipate it will allow for the
planning of a future definitive randomized clinical trial. The aims of this pilot trial are
to assess the feasibility of safely continuing metformin, or taking salsalate on the day of
surgery, with the goal of reducing the incidence of hyperglycemic events. This includes
assessing our ability to recruit patients, adhere to the proposed study protocol, assess
workload,and measure the desired outcomes, all of which are crucial for the planning of a
subsequent clinical trial.