Hyperglycemia in Renal Transplantation

What Was Tested

The trial (not phased) is built around Insulin (regular human).

Based on multiple prior studies, kidney transplant recipients with diabetes are at higher risk for poor initial graft function after transplant.

It had two arms (groups): Tight glucose control (experimental) and Standard glucose control (active comparator).

The registry classes the interventions as drug.

More on the Plan

Population- their study population will include all adult diabetic patients undergoing deceased donor renal transplantation or living donor transplantation in which a swap requires transportation and resulting cold storage time.

This will ensure a reasonable incidence of their primary outcome (poor short term graft function) and eliminate the potential risk of treating non-diabetic patients with insulin infusions.

Patients already enrolled in a drug trial designed to study the impact of the drug on graft function will be excluded.

Study Design- This will be a randomized control trial.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: End stage renal disease undergoing cadaveric renal transplant.

The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: enrolled in concurrent study to test impact of a drug on graft function after transplant.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2012-08 with completion listed for 2014-08.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Incidence of Poor Graft Function After Kidney Transplant (time frame: 7 days after transplant).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 60 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.