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Characterization of Brachial Arterial t-PA Release, Endothelial Function, Obesity and Inflammation
Plain-language guide to NCT00780481: not phased interventional trial of Bradykinin, 13 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00780481
- Phase
- not phased
- Status
- terminated early
- Start
- 2007-01
- Completion (planned or actual)
- 2011-01
- Participants
- 13 (actual)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Obesity
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Bradykinin.
T-PA release is impaired in obese subjects.
In order to have a better mechanistic understanding of t-PA release, the researchers will compare t-PA release to Flow Mediated Vasodilation, Radial Artery Tonometry, and other markers of endothelial function and oxidative stress.
It had 1 arm (groups): Bradykinin (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 13 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Adults 18 years and greater.
The full record lists 2 inclusion and 14 exclusion criteria; among the exclusions: PVC \< 30; hypertensive subjects on ace inhibitors; pregnant or nursing mothers.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Bradykinin 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 2007-01 with completion listed for 2011-01.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Peak t-PA Release (time frame: Single Study day).
It also tracked 3 secondary outcomes, for example Peak FMD, Radial Artery Elasticity and Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.
What This Means in Plain Language
Put simply, this is a not phased trial of Bradykinin in 13 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
More context: the Bradykinin compound page, all human trials.
Our Notes on the Compound
Bradykinin: A 9-amino-acid peptide that widens blood vessels and causes swelling; given in research studies of blood flow.
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.