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

Phase 4

Withdrawn

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT02571608
• Lead Sponsor: McMaster University

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-08
• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ages 18 - 75, using metformin for control of Type II Diabetes mellitus, American Society of Anesthesiologists(ASA) I, II and III, informed consent, surgery in which less than 1000 mL of blood loss is expected.

Read More

Exclusion Criteria

• renal failure, liver failure, Congestive heart failure (CHF), previous episodes of hypoglycemia, conditions which mask symptoms of hypoglycemia (autonomic neuropathy or chronic high dose beta-blocker usage), low capillary blood sugar (CBG) (≤4.0 mmol/L) at pre-operative appointment date, same day surgery, any patient who received contrast dye within 2 days of the planned surgery or requires intra-operative contrast dye and same day surgery.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Metformin	Metformin	Metformin, dosage same as the patient's regular dosage

Primary Outcome Measures

Name	Time	Method
Recruitment rate	One year	This will be documented as total number of individuals recruited and randomized in the study.

Secondary Outcome Measures

Name	Time	Method
Glycemic control	Baseline, Intra-op, 1, 6, 12, 24 and 48 hours post-op	Mean CBG score difference between 2 groups
Wound infection	At follow up visit with surgeon at approx. 6 weeks post-surgery	Wound infection present at follow-up visit
Length of Hospital Stay	One year	Mean length of stay for all patients