Type 2 Diabetes and Ambulatory Surgery Patients

NCT03179254 | Completed Phase 4

• 1 other identifier: STU 032011-162
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients scheduled to undergo ambulatory surgery are usually made non per os (NPO) at midnight on the day prior to surgery. In the case of patients with type 2 diabetic mellitus (DM) on treatment with oral hypoglycemic agent (OHA), patients are instructed to temporarily discontinue treatment on the day prior to surgery. This advice is based on the concern for intraoperative and postoperative hypoglycemia in this group of patients. Metformin , a dimethylbiguanide, is widely used as an oral antihyperglycemic drug in the long term treatment of type 2 DM. This instruction to withhold treatment may be imprudent given that metformin by virtue of its mechanism of action does not cause hypoglycemia. Another concern often cited as a reason to withhold metformin is the reported adverse effect of lactic acidosis. However, a recent metanalysis by the Cochrane group found no cases of fatal or nonfatal lactic acidosis in 70,490 patient-years of metformin use, or in 55,451 patient-years for those not on metformin. Furthermore, discontinuing OHA treatment can result in disruption of established glycemic control and intraoperative and postoperative hyperglycemia all of which can be deleterious to the patient. We hypothesize that uninterrupted treatment with OHA in type 2 DM patients undergoing ambulatory surgery will not result in intraoperative and postoperative hypoglycemia (defined as blood glucose \< 60mg/dl) compared to patients withholding OHA treatment on the day of surgery.

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

• Postoperative blood glucose level

  Postoperative blood glucose level

  Within 1 hour arrival of the Postanesthesia Care Unit (PACU)

Study Arms (2)

Oral hypoglycemic agent continue

EXPERIMENTAL

Metformin continue on the day of surgery

Drug: Metformin continue

Oral hypoglycemic agent discontinue

ACTIVE COMPARATOR

Metformin discontinue on the day of surgery

Drug: Metformin discontinue

Interventions

Metformin continue DRUG

Oral hypoglycemic agent continue on the day of ambulatory surgery

Also known as: Metformin

Oral hypoglycemic agent continue

Metformin discontinue DRUG

Oral hypoglycemic agent discontinue on the day of ambulatory surgery

Also known as: Metformin

Oral hypoglycemic agent discontinue

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18-80 years old
• Established diagnosis of type 2 diabetes mellitus
• Undergoing ambulatory surgery.
• Receiving OHA treatment for diabetes .

You may not qualify if:

• Treatment of insulin monotherapy
• Treatment with combination of oral hypoglycemic agents such as Thiazolidinediones-Repaglimide (Prandin), Rosiglitazone (Avandia), Pioglitazone (Actos).
• Renal Insufficiency with Serum Creatinine \> 2mg/dl
• Decompensated congestive heart failure decompensated congestive heart failure

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Related Publications (2)

• Gasanova I, Meng J, Minhajuddin A, Melikman E, Alexander JC, Joshi GP. Preoperative Continuation Versus Interruption of Oral Hypoglycemics in Type 2 Diabetic Patients Undergoing Ambulatory Surgery: A Randomized Controlled Trial. Anesth Analg. 2018 Oct;127(4):e54-e56. doi: 10.1213/ANE.0000000000003675.

  PMID: 30044293 DERIVED

• Zerillo J, Agarwal P, Poeran J, Zubizarreta N, Poultsides G, Schwartz M, Memtsoudis S, Mazumdar M, DeMaria S Jr. Perioperative Management in Hepatic Resections: Comparative Effectiveness of Neuraxial Anesthesia and Disparity of Care Patterns. Anesth Analg. 2018 Oct;127(4):855-863. doi: 10.1213/ANE.0000000000003579.

  PMID: 29933267 DERIVED

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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 7, 2017
• Study Start: March 22, 2010
• Primary Completion: January 10, 2014
• Study Completion: August 26, 2014
• Last Updated: June 12, 2017

Record last verified: 2017-06