Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects

What Was Tested

In this phase 1 trial, researchers set out to test BNP (Nesiritide) for insulin resistance, prediabetes & type 2 diabetes.

The purpose of the study is to compare the effects of nesiritide to placebo administered by a continuous IV infusion over 48 hours for the treatment of insulin resistance in healthy, obese, insulin resistant individuals.

It had two arms (groups): Obese nondiabetic insulin resistant subjects- Panel A (active comparator) and Obese nondiabetic insulin resistant subjects- Panel B (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 6 actual participants took part.

It was open to people of any sex aged from 40 years up to 65 years.

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

Examples of who could join: Age 40-65 years inclusive. Men and women. Able to provide written, informed consent. Weight stable (± 3 kg) during the 3 months prior to enrollment. BMI ≥ 30 kg/m2; body weight ≤ 106 kg.

The full record lists 6 inclusion and 20 exclusion criteria; among the exclusions: known coronary artery disease, angina or heart failure; bleeding disorders; acute or chronic infections.

How the Study Was Run

Design: randomized, crossover and double-blind.

Because people in this BNP (Nesiritide) 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 BNP (Nesiritide) and the comparison at some point, usually with a gap in between.

As a double-blind BNP (Nesiritide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2017-07-13 with completion listed for 2018-09-24.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of BNP (Nesiritide) in 6 people with insulin resistance, prediabetes & type 2 diabetes.

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 BNP (Nesiritide) compound page, Insulin resistance, prediabetes & type 2 diabetes research.