drugset / Trial / NCT03397966

Metabolic Effects of Natriuretic Peptide Hormones

NCT03397966 ↗

Phase 4 Terminated 5 enrolled VA Office of Research and Development
RandomizedCrossoverTriple-blindOther

Summary

Accumulating evidence suggests that the natriuretic peptide (NP) hormonal system has important effects on metabolism. However, more information is needed to better understand the effects of NPs on metabolism in humans. Therefore, the investigators propose a study to determine the effects of b-type natriuretic peptide (BNP) on energy and fat metabolism in humans. The investigators' primary hypothesis is that the administration of BNP will increase energy expenditure in humans. The investigators' secondary hypothesis is that BNP administration will promote changes in gene expression in fat tissue suggestive of fat "beiging" in humans. Interventions that safely increase energy expenditure and promote fat "beiging" represent potential strategies for treating metabolic dysfunction due to obesity.

Timeline

Start
2018-07-01
Primary completion
2019-05-01
Completion
2019-05-01

Outcome

Missed primary endpoint

Stopped: “Study drug no longer available”

registry analysis (superiority test); BNP Infusion vs Placebo (Control); p = 0.063; Mixed Models Analysis NCT03397966 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject BNP(1-32) Peptide 10 unknown Intravenous

Indications