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

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human) for gum disease (periodontal) & oral health.

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.

In the time period directly before, during, and after surgery, maintenance of blood sugar within normal physiological range is essential.

It had two arms (groups): Patients with diabetes and ESRD (other) and Patients with diabetes and no ESRD (other).

Patients with diabetes and end stage renal disease (ESRD).

Patients with diabetes and no end stage renal disease (ESRD).

The registry classes the interventions as drug.

More on the Plan

Relevant kidney function data, such as GFR, will also be obtained, if available.

The surgical procedures will include but are not limited to the following elective surgeries: major abdominal surgery, major GU/GYN surgeries, vascular surgery, renal transplantation, neurosurgery, vascular and orthopedic surgery .

The investigators expect patients in both groups to undergo similar surgical procedures.

All medications prescribed to the patient will be noted, as will the type of diabetes the patient has, type 1 or type 2.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Baseline chemistry with a potassium at or above 3.5.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2018-05-01 with completion listed for 2020-09-03.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Change in blood glucose level (time frame: one hour).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin (regular human) in 40 people with gum disease (periodontal) & oral health.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Gum disease (periodontal) & oral health research.