B-type Natriuretic Peptide and Glucose Metabolism

What Was Tested

In this not phased trial, researchers set out to test BNP (Nesiritide).

Rationale: B type natriuretic peptide (BNP) is a hormone released from cardiomyocytes in response to myocyte stretching and serves as a reliable biomarker in the diagnosis of cardiac dysfunction and heart failure.

Recent observations speak for a distinct connection between chronic heart failure and diabetes mellitus.

Objective: The study was set out to investigate the role of BNP on parameters of glucose metabolism in a placebo controlled cross-over study in healthy volunteers.

It had two arms (groups): B-type natriuretic peptide (active comparator) and Placebo (placebo comparator).

The effect of B-type natriuretic peptide on glucose metabolism will be compared with placebo during an intravenous glocose tolerance test.

Comparison of the effect of b-type natriuretic peptide on glucose metabolism and placebo.

The registry classes the interventions as drug.

More on the Plan

In one of their recent studies the researchers investigated insulin sensitivity (OGIS index) and insulin secretion (beta cell function with the insulinogenic index, IGI) in patients with heart insufficiency by frequently sampled oral glucose tolerance test (21).

The relationship between BNP and glucose metabolism has only been partially investigated.

Plasma BNP rises in response to hyperglycemia, but is not influenced by hyperinsulinemia (22, 23).

On the other side, the physiological role of BNP on beta cell function and insulin sensitivity has not been investigated to date.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to men only aged from 18 years up to 40 years.

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

How the Study Was Run

Design: randomized, crossover and single-blind.

Random assignment meant chance, not the researchers, decided who got BNP (Nesiritide) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both BNP (Nesiritide) and the comparison in turn, acting as their own control.

In this single-blind BNP (Nesiritide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2010-05 with completion listed for 2010-10.

It ran at 1 site in Austria.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): glucose (time frame: 0 to 180 minutes).

It also tracked 1 secondary outcome, for example insulin, c-peptide.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of BNP (Nesiritide) in 10 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 BNP (Nesiritide) compound page, all human trials.