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Pilot: Insulin Sensitivity/Management in Hyperglycemic Patients in Perioperative Period ESRD/Non-ESRD

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03526536
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ketan Shevde, MD, State University of New York - Downstate Medical Center

Brief Summary:
This study is for people with diabetes who have either healthy kidneys or who have end stage renal disease (ESRD) and are on hemodialysis that are having surgery. This research will help increase our knowledge about how having diseased kidneys and being on hemodialysis changes how the body responds to insulin. In the time period directly before, during, and after surgery, maintenance of blood sugar within normal physiological range is essential. When patients come for surgery and have an elevated blood sugar, it is up to each individual physician to decide on the right amount of insulin to treat them. Currently, there are many different protocols across the country to treat elevated blood sugar; however, there is no one specific protocol to treat elevated blood sugar at SUNY Downstate Medical Center at this time. In this study, the investigators will evaluate the change in blood sugar following insulin administration to determine whether there is a significantly different response between ESRD and non-ESRD patients. The results of the study will help develop safer practice guidelines to patients with ESRD with an elevated blood sugar while they are having surgery.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Diabetes Mellitus Drug: IV Novolin R human insulin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Comparison of Insulin Sensitivity and Management in Hyperglycemic Patients in the Perioperative Period: ESRD vs. Non-ESRD
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Patients with diabetes and ESRD
Patients with diabetes and end stage renal disease (ESRD)
Drug: IV Novolin R human insulin
Novolin R human insulin, Novo Nordisk Inc. Plainsboro, NJ
Other Name: Novolin R human insulin, Novo Nordisk Inc. Plainsboro, NJ

Patients with diabetes and no ESRD
Patients with diabetes and no end stage renal disease (ESRD)
Drug: IV Novolin R human insulin
Novolin R human insulin, Novo Nordisk Inc. Plainsboro, NJ
Other Name: Novolin R human insulin, Novo Nordisk Inc. Plainsboro, NJ




Primary Outcome Measures :
  1. Change in blood glucose level [ Time Frame: one hour ]
    Change in blood glucose level measures using a glucometer (Nova Biomedical, Waltham, MA. USA)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adult patients over 18 years old with diabetes (both sexes) presenting without any kidney disease or with ESRD on hemodialysis
  • Undergoing major elective surgery procedures such as abdominal, pulmonary, GU/GYN, vascular, renal, neurologic, and orthopedic surgery
  • Signed informed consent for the study.
  • Patients with elevated preoperative blood glucose of a value > 150 mg/dL or < 350 mg/dL
  • English-speaking
  • Baseline chemistry with a potassium at or above 3.5

Exclusion criteria:

  • Patients under the age of 18.
  • Pregnant women. (Pregnant women have altered glucose metabolism; specific insulin regimen used for pregnant women)
  • Patient does not give informed consent for the study.
  • Patient does not have decisional capacity or a surrogate.
  • Patient cannot understand or read English.
  • Patients with a preoperative blood glucose < 150 mg/dL or >350 mg/dL
  • Patients without diabetes
  • Patients with kidney disease that are not on hemodialysis
  • A history of frequent hypoglycemia in the month prior to surgery by history or a change in insulin dose for hypoglycemia in the month prior to surgery
  • Patients taking steroids or patients that will receive steroids during their surgery
  • Any patients who refuse to remain NPO except water in the two hour window after their last insulin dose
  • Patients scheduled for cardiac, thoracic and emergency surgeries
  • Patients who have taken or received insulin or oral hypoglycemic agents after 12 am on the day of surgery.
  • Patients have not adhered to the NPO status.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526536


Contacts
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Contact: Joanna Serafin, PhD 718-613-8742 joanna.serafin@downstate.edu
Contact: Ketan Shevde, MD 718-270-1563 ketan.shevde@downstate.edu

Locations
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United States, New York
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Ketan Shevde, MD    718-613-8742    ketan.shevde@downstate.edu   
Contact: Joanna Serafin, PhD    718-613-8742    joanna.serafin@downstate.edu   
Sponsors and Collaborators
State University of New York - Downstate Medical Center
Investigators
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Principal Investigator: Ketan Shevde, MD State University of New York - Downstate Medical Center

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Responsible Party: Ketan Shevde, MD, MD; Professor of Clinical Anesthesia; Vice-Chair for Research, State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT03526536    
Other Study ID Numbers: 1114056
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Insulin Resistance
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs