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Type 2 Diabetes and Ambulatory Surgery Patients (Diabetes)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03179254
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Jin Meng, University of Texas Southwestern Medical Center

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.


Condition or disease Intervention/treatment Phase
Diabetes Type 2 Drug: Metformin continue Drug: Metformin discontinue Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Oral Hypoglycemic Agent Continuation Versus Interruption in Type 2 Diabetic Patients Undergoing Ambulatory Surgery
Actual Study Start Date : March 22, 2010
Actual Primary Completion Date : January 10, 2014
Actual Study Completion Date : August 26, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral hypoglycemic agent continue
Metformin continue on the day of surgery
Drug: Metformin continue
Oral hypoglycemic agent continue on the day of ambulatory surgery
Other Name: Metformin

Active Comparator: Oral hypoglycemic agent discontinue
Metformin discontinue on the day of surgery
Drug: Metformin discontinue
Oral hypoglycemic agent discontinue on the day of ambulatory surgery
Other Name: Metformin




Primary Outcome Measures :
  1. Postoperative blood glucose level [ Time Frame: Within 1 hour arrival of the Postanesthesia Care Unit (PACU) ]
    Postoperative blood glucose level



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jin Meng, Medical Doctor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03179254     History of Changes
Other Study ID Numbers: STU 032011-162
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs