Natriuretic Peptides and Metabolic Risk in Obesity

What Was Tested

The trial (early phase 1) is built around Insulin (regular human) and BNP (Nesiritide).

The investigators are examining: 1. the relationships of insulin levels and natriuretic peptide hormone levels, and 2. the effects of administering an infusion of natriuretic peptide hormone on the breakdown of fat in healthy lean and otherwise healthy obese individuals.

It had three arms (groups): Saline Infusion (placebo comparator), Insulin Clamp (experimental) and BNP Infusion (Nesiritide) (experimental).

All subjects will undergo 3 interventions, performed at 3 separate outpatient study visits. The order of the 3 interventions will be randomly assigned. The interventions are: Saline Infusion, Insulin Clamp, and BNP Infusion (Nesiritide).

All subjects will undergo 3 interventions, performed at 3 separate outpatient study visits. The order of the 3 interventions will be randomly assigned. The interventions are: Saline Infusion, Insulin Clamp, and BNP Infusion (Nesiritide).

All subjects will undergo 3 interventions, performed at 3 separate outpatient study visits. The order of the 3 interventions will be randomly assigned. The interventions are: Saline Infusion, Insulin Clamp, and BNP Infusion (Nesiritide).

The registry classes the interventions as drug and other.

More on the Plan

The cardiac natriuretic peptide hormonal system may protect against the development of cardiometabolic risk.

Understanding the mechanisms behind the "natriuretic peptide deficiency" of obesity would illuminate an important way in which obesity interacts with the cardiovascular system.

The investigators propose a prospective cross-over design in 40 healthy lean and otherwise healthy obese individuals.

The investigators propose the following specific aims and hypotheses: Aim 1: To study the effect of hyperinsulinemia on the response of the natriuretic peptide system to salt loading.

Who Took Part

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Men and women ages 18-50 years. BMI 18 to \<25 kg/m2 (lean group, N=20) or BMI 30 to \<40 kg/m2 (obese group, N=20).

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: current use of antihypertensive medications; current use of glucocorticoids, metformin, or any antidiabetes medications; prior or current cardiovascular disease, renal disease, or liver disease.

How the Study Was Run

Design: non-randomized, crossover and open-label.

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

Being open-label, the Insulin (regular human) study did not mask who received what.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Change in natriuretic peptide levels (time frame: 4 hours (during 2-hour study infusions and for 2 hours after study infusions)). Change in glycerol levels (time frame: 1 hour).

It also tracked 3 secondary outcomes, for example Change in free fatty acid levels, Change in triglyceride levels and Change in energy expenditure assessed by indirect calorimetry.

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Insulin (regular human) and BNP (Nesiritide) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the BNP (Nesiritide) compound page, all human trials.