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Effects of Empagliflozin in Reducing Oxidative Stress After Kidney Transplantation
Plain-language guide to NCT04918407: not phased randomized trial of Insulin (regular human), 40 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04918407
- Phase
- not phased
- Status
- completed
- Start
- 2022-01-01
- Completion (planned or actual)
- 2025-07-05
- Participants
- 40 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Kidney Transplant; Complications
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Insulin (regular human).
The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes after kidney transplantation.
The study is randomised and double-blinded.
It had two arms (groups): Empagliflozin (experimental) and Insulin alone (active comparator).
Just contriling the blood glucose with Insulin.
The registry classes the interventions as drug.
Who Took Part
40 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: Diagnosed with type 2 diabetes. Post kidney transplant. Stable graft function.
The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: pancreas and kidney transplant; history of recurrent urinary tract infection.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.
The Insulin (regular human) group and the comparison group ran side by side rather than switching.
As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2022-01-01 with completion listed for 2025-07-05.
It ran at 2 sites in Iran (2).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: serum level of superoxide dismutase (time frame: Change from baseline after 90 days of intervention).
It also tracked 1 secondary outcome, for example Plasma levels of malondialdehyde.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Insulin (regular human) in 40 people.
The trial is marked completed; 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.