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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
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 2, 2017
    Last Updated
    June 8, 2017
    Sponsor
    University of Texas Southwestern Medical Center
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    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

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    Type 2 Diabetes and Ambulatory Surgery Patients

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