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The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI)
Plain-language guide to NCT00592410: phase 2 interventional trial of Insulin (regular human). Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00592410
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2007-02
- Completion (planned or actual)
- 2008-11
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Acute Renal Failure
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Insulin (regular human).
The researchers propose to determine the acute metabolic effects of intensive insulin therapy when administered to AKI patients with a particular focus on its effects on protein metabolism.
The researchers also hypothesize that this therapy will have favorable effects on the inflammatory and oxidative stress profile of patients with AKI.
It had 1 arm (groups): 1 (experimental).
The registry classes the interventions as drug.
Who 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: Adults ≥ 18 years of age admitted to the intensive care unit. New onset acute kidney injury (AKI) or AKI superimposed on chronic kidney disease. AKI will be defined as:. Patients will be recruited for the study within 3-5 days following establishment of AKI.
The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: institutionalized patient; unable to obtain consent from subject or legally recognized representative; patients receiving insulin within 12 hours of the study or patients with known diabetes mellitus.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2007-02 with completion listed for 2008-11.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: A change in whole body and muscle protein breakdown during amino acid supplementation with insulin versus baseline (time frame: 6 hours).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Insulin (regular human) in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
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.