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Study of Glycemic Control on Liver Transplantation Outcomes
Plain-language guide to NCT01211730: phase 4 randomized trial of Insulin (regular human), 164 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01211730
- Phase
- phase 4
- Status
- completed
- Start
- 2009-04
- Completion (planned or actual)
- 2015-12
- Participants
- 164 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Evidence of Liver Transplantation; Hyperglycemia; Rejection
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Insulin (regular human).
It had two arms (groups): 140 Group (active comparator) and 180 Group (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 164 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Require Liver Transplantation. Age 18 - 80. Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious. Expected survival following transplantation for \> 1 year.
The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: inability of patient or family member to give informed consent; not expected to survive for \> 1 year following liver transplantation; previous liver transplantation.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
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 2009-04 with completion listed for 2015-12.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Rejection of Liver Transplant (time frame: within 1 year of transplantation).
It also tracked 5 secondary outcomes, for example Hypoglycemia, Infection Rates, Rehospitalization Rates and Overall Graft Survival at 1 Year.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 164 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.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.