CompletedNCT03035929Updated Jun 20, 2019Results posted

Diagnosing Natriuretic Peptide Deficiency

A Phase 1 interventional study of Dexamethasone in Healthy and Lean, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-20.

Sponsored by Vanderbilt University Medical Center · Phase 1, Interventional, and Diagnostic

Phase: Phase 1
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 18 Years to 50 Years
Sex: All

Study summary

In this pilot study, the investigators will determine the response of the natriuretic peptide (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The goal of the proposed project is to generate preliminary data that will be used to develop power calculations, inform cutoff ranges, and inform the timing of the NP response for larger subsequent studies.

Aim: To determine the range of distribution and time course of natriuretic peptide (NP) responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.

Hypothesis: Determination of the NP responses (the range and time course of changes in NP levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency of blood sampling in a definitive prospective study, as well as enable investigators to perform a sample size calculation for a definitive prospective study.

Read the detailed description

see above

Conditions studied

Healthy
Lean

In context

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Men and women ages 18-50 years
BMI 18.5 to \<25 kg/m\^2

Exclusion criteria

Exclusion Criteria:

Significant use of systemically-absorbed glucocorticoids currently or for an extended period of time during the prior 6 months
Current use of antihypertensive medications
Current use of metformin, or any antidiabetic medications (which could affect glucose and insulin levels)
Current use of medications known to affect dexamethasone metabolism, including phenytoin, rifampin, carbamazepine, troglitazone, and barbiturates
Active, clinically significant infection at time of visit
History of adrenal insufficiency or Cushing's syndrome
Prior or current cardiovascular disease, renal disease, or liver disease
Diabetes mellitus, pre-diabetes, impaired fasting glucose, or impaired glucose tolerance
Atrial fibrillation
Bleeding disorder or anemia
Elevated Liver Functions Tests > 2 times upper limit of normal
Estimated glomerular filtration rate \< 60 ml/min
HbA1c > 5.7
Abnormal sodium or potassium level
Positive pregnancy test, women of child-bearing age not practicing birth control, women who are breastfeeding

Study design

Phase: Phase 1
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

Experimental
Healthy
10 Healthy subjects will undergo study procedures at four study visits. All subjects will undergo the same procedures and interventions.
Drug: Dexamethasone

Interventions

DrugDexamethasone
A single dose of dexamethasone IV 4 mg will be administered.
Also known as: Dexamethasone IV

What researchers measure

Primary outcomes

Changes in NT-proANP From Baseline to 8 Hours
Change in natriuretic peptide levels after drug administration
Time frame: baseline and 8 hours
Changes in NT-proBNP From Baseline to 8 Hours
Change in natriuretic peptide levels after drug administration
Time frame: Baseline and 8 hours

Secondary outcomes

Changes in NT-proANP
Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
Time frame: baseline, 24 hours, 48 hours and 72 hours
Changes in NT-proBNP
Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
Time frame: at baseline, 24 hours, 48 hours and 72 hours
BNP (B-type Natriuretic Peptide)
Natriuretic peptide levels after drug administration
Time frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
ANP (Atrial Natriuretic Peptide)
Natriuretic peptide levels after drug administration
Time frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

Results

Posted Jun 20, 2019

Participant flow

Participant flow — Overall Study
Milestone	Healthy
Started	10
Completed	10
Not completed	0

Outcome measures

PrimaryChanges in NT-proANP From Baseline to 8 Hours

Change in natriuretic peptide levels after drug administration

Time frame:: baseline and 8 hours
Reported as:: Mean · nmol/l

Changes in NT-proANP From Baseline to 8 Hours
nmol/l	Healthy
Changes in NT-proANP From Baseline to 8 Hours	-0.33 ± 0.25

PrimaryChanges in NT-proBNP From Baseline to 8 Hours

Change in natriuretic peptide levels after drug administration

Time frame:: Baseline and 8 hours
Reported as:: Mean · pg/ml

Changes in NT-proBNP From Baseline to 8 Hours
pg/ml	Healthy
Changes in NT-proBNP From Baseline to 8 Hours	18.4 ± 20.3

SecondaryChanges in NT-proANP

Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours

Time frame:: baseline, 24 hours, 48 hours and 72 hours
Reported as:: Mean · nmol/l

Changes in NT-proANP
nmol/l	Healthy
Change from baseline to 24 hours	-0.23 ± .22
Change from baseline to 48 hours	0.17 ± .36
Change from baseline to 72 hours	-0.05 ± .33

SecondaryChanges in NT-proBNP

Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours

Time frame:: at baseline, 24 hours, 48 hours and 72 hours
Reported as:: Mean · pg/ml

Changes in NT-proBNP
pg/ml	Healthy
Change from baseline to 24 hours	-5.0 ± 26.9
Change from baseline to 48 hours	-23.4 ± 41.4
Change from baseline to 72 hours	-16.9 ± 39.6

SecondaryBNP (B-type Natriuretic Peptide)

Natriuretic peptide levels after drug administration

Time frame:: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

No measurements were reported for this outcome.

SecondaryANP (Atrial Natriuretic Peptide)

Natriuretic peptide levels after drug administration

Time frame:: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

No measurements were reported for this outcome.

Adverse events

Collected over 48 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Healthy	0/10 (0%)	0/10 (0%)	1/10 (10%)

Most frequent other events

Most frequent other events
Event	Healthy
NauseaGastrointestinal disorders	1/10

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Healthy
Median	27.5 (24.5 to 29.0)

Sex: Female, Male
Sex: Female, Male(Participants)	Healthy
Female	10
Male	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Healthy
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	2
White	7
More than one race	1
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(Participants)	Healthy
United States	10

Study locations

1 site

Vanderbilt University Medical Center
Nashville, Tennessee 37203, United States

References and documents

Study documents

Protocol and statistical analysis plan · Aug 18, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03035929
Lead sponsor: Vanderbilt University Medical Center
Responsible party: Katherine N. Bachmann, MD (Instructor in Medicine, Vanderbilt University Medical Center) — Principal investigator
First posted: Jan 30, 2017
Start date: Jan 1, 2017
Primary completion: Jun 8, 2017
Completion: Jan 1, 2018
Results posted: Jun 20, 2019
Last update: Jun 20, 2019

Study contacts

Katherine N Bachmann, MD

principal investigator · Vanderbilt Endocrinology

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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