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Role of Angiotensin II in Insulin-induced Microvascular Activity

Plain-language guide to NCT01024543: not phased randomized trial of Angiotensin II, 18 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01024543
Phase
not phased
Status
completed
Start
2006-10
Completion (planned or actual)
2009-11
Participants
18 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Insulin Sensitivity; Microcirculation
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Angiotensin II.

It had three arms (groups): Placebo (sham comparator), Angiotensin II (experimental) and Phenylephrine (active comparator).

Placebo.

Angiotensin II.

Phenylephrine.

The registry classes the interventions as drug.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Years 2.Caucasian 3.Blood pressure \<140/90 mmHg.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: obesity (bmi\>27kg/m2); cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure); impaired glucose tolerance or diabetes mellitus according to the criteria of the ada.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Because people in this Angiotensin II study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Angiotensin II and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Angiotensin II.

Those kept unaware of assignments: participant and investigator.

It started in 2006-10 with completion listed for 2009-11.

It ran at 1 site in Netherlands.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): functional recruitment of capillaries in the skin (time frame: January 2009).

It also tracked 3 secondary outcomes, for example perfused capillary density in the nailfold, Endothelium- (in)dependent vasodilatation of finger skin microcirculation and Insulin sensitivity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Angiotensin II in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Angiotensin II compound page, all human trials.

Our Notes on the Compound

Angiotensin II: An 8-amino-acid hormone that narrows blood vessels; synthetic angiotensin II (Giapreza) is used for low blood pressure in shock.

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.