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Caveolin-1 and Vascular Dysfunction

Plain-language guide to NCT01426529: phase 1 non-randomized trial of Angiotensin II, insulin resistance, prediabetes & type 2 diabetes, 120 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01426529
Phase
phase 1
Status
active, not recruiting
Start
2010-10-01
Completion (planned or actual)
2026-10-15
Participants
120 (estimated)
Design
non-randomized, open label (everyone knows who gets what), other
Conditions studied
Hypertension; Insulin Resistance
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 1 trial tested Angiotensin II for insulin resistance, prediabetes & type 2 diabetes.

There are two parts of the investigators research program.

It had two arms (groups): major allele homozygous (experimental) and minor allele carriers (experimental).

The researchers will compare this arm with the minor allele carrier arm.

The researchers will compare this arm with the major allele homozygous arm.

The registry classes the interventions as drug.

Who Took Part

120 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Mild to moderate hypertension. No other major illnesses. BMI \< or equal to 40.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: secondary illnesses; BMI \> 40; taking 4 or more anti-hypertensive medications.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Nothing was hidden in this open-label Angiotensin II study: the insulin resistance, prediabetes & type 2 diabetes 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 2010-10-01 with completion listed for 2026-10-15.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Genetic Variation at the Caveolin-1 Locus (time frame: 5 years).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Angiotensin II in 120 people with insulin resistance, prediabetes & type 2 diabetes.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Angiotensin II compound page, Insulin resistance, prediabetes & type 2 diabetes research.

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.