Type 2 Diabetes and Ambulatory Surgery Patients (Diabetes)
Primary Purpose
Diabetes Type 2
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Metformin continue
Metformin discontinue
Sponsored by

About this trial
This is an interventional prevention trial for Diabetes Type 2
Eligibility Criteria
Inclusion Criteria:
- Men and women 18-80 years old
- Established diagnosis of type 2 diabetes mellitus
- Undergoing ambulatory surgery.
- Receiving OHA treatment for diabetes .
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oral hypoglycemic agent continue
Oral hypoglycemic agent discontinue
Arm Description
Metformin continue on the day of surgery
Metformin discontinue on the day of surgery
Outcomes
Primary Outcome Measures
Postoperative blood glucose level
Postoperative blood glucose level
Secondary Outcome Measures
Full Information
NCT ID
NCT03179254
First Posted
June 2, 2017
Last Updated
June 8, 2017
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03179254
Brief Title
Type 2 Diabetes and Ambulatory Surgery Patients
Acronym
Diabetes
Official Title
Oral Hypoglycemic Agent Continuation Versus Interruption in Type 2 Diabetic Patients Undergoing Ambulatory Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 22, 2010 (Actual)
Primary Completion Date
January 10, 2014 (Actual)
Study Completion Date
August 26, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Patients with established diagnosis of type 2 Diabetes Mellitus (DM) who are on OHA monotherapy or combination OHA and are scheduled to undergo ambulatory surgery will be identified. Informed consent will be obtained from 160 consecutive study participants. Patients will be randomized into 2 groups - OHA treatment on day of surgery (Metformin continue) (H1 group, n= 80) and patients not receiving OHA on day of surgery (OHA discontinue) (H0, n=80) as prescribed by their provider. All patients will be processed through the anesthesia preoperative clinic and instructions regarding preoperative medication handling will be provided to study participants by the investigator. The instructions will be reinforced by the clinic nursing staff in the usual fashion.
On the morning of the surgical procedure, the investigator will verify that medication administration instructions provided to the study participant was adhered to. The patient will be checked-in into the ambulatory surgery suite and usual surgical preparatory procedures followed. Pre-anesthesia capillary blood glucose measurement will be performed and recorded in the pre-surgical area.
Anesthesia will be induced and maintained in the usual fashion. Intraoperative capillary blood glucose levels will be checked and recorded.The investigator will ensure that glucose containing maintenance intravascular fluids are avoided throughout the anesthesia and surgery unless specifically indicated for treatment. All patients will be awakened and extubated at the end of surgery and transferred to the post anesthesia recovery (PAR) area as appropriate. Capillary blood glucose will be measured after arrival in the PAR. The capillary glucose tests obtained in this study is part of established and standard care and will be paid for by the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral hypoglycemic agent continue
Arm Type
Experimental
Arm Description
Metformin continue on the day of surgery
Arm Title
Oral hypoglycemic agent discontinue
Arm Type
Active Comparator
Arm Description
Metformin discontinue on the day of surgery
Intervention Type
Drug
Intervention Name(s)
Metformin continue
Other Intervention Name(s)
Metformin
Intervention Description
Oral hypoglycemic agent continue on the day of ambulatory surgery
Intervention Type
Drug
Intervention Name(s)
Metformin discontinue
Other Intervention Name(s)
Metformin
Intervention Description
Oral hypoglycemic agent discontinue on the day of ambulatory surgery
Primary Outcome Measure Information:
Title
Postoperative blood glucose level
Description
Postoperative blood glucose level
Time Frame
Within 1 hour arrival of the Postanesthesia Care Unit (PACU)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women 18-80 years old
Established diagnosis of type 2 diabetes mellitus
Undergoing ambulatory surgery.
Receiving OHA treatment for diabetes .
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30044293
Citation
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.
Results Reference
derived
PubMed Identifier
29933267
Citation
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.
Results Reference
derived
Learn more about this trial
Type 2 Diabetes and Ambulatory Surgery Patients
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