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

NCT02571608 | Withdrawn Phase 4

• 1 other identifier: 15-152
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus Type 2

Keywords

Type 2 diabetes mellitus, Metformin, peri-operative

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  This will be documented as total number of individuals recruited and randomized in the study.

  One year

Secondary Outcomes (3)

• Glycemic control

  Baseline, Intra-op, 1, 6, 12, 24 and 48 hours post-op

• Wound infection

  At follow up visit with surgeon at approx. 6 weeks post-surgery

• Length of Hospital Stay

  One year

Study Arms (2)

Metformin

ACTIVE COMPARATOR

Metformin, dosage same as the patient's regular dosage

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Metformin DRUG

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.

Also known as: Group A

Metformin

Placebo DRUG

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.

Also known as: Group B

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• James Paul, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

• Russell Brown, MDMC, PhD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 8, 2015
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 8, 2021

Record last verified: 2021-10