NCT03035929

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 20, 2019

Completed
Last Updated

June 20, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

January 25, 2017

Results QC Date

August 20, 2018

Last Update Submit

March 20, 2019

Conditions

HealthyLean

Outcome Measures

Primary Outcomes (2)

  • Changes in NT-proANP From Baseline to 8 Hours

    Change in natriuretic peptide levels after drug administration

    baseline and 8 hours

  • Changes in NT-proBNP From Baseline to 8 Hours

    Change in natriuretic peptide levels after drug administration

    Baseline and 8 hours

Secondary Outcomes (4)

  • Changes in NT-proANP

    baseline, 24 hours, 48 hours and 72 hours

  • Changes in NT-proBNP

    at baseline, 24 hours, 48 hours and 72 hours

  • BNP (B-type Natriuretic Peptide)

    0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

  • ANP (Atrial Natriuretic Peptide)

    0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

Study Arms (1)

Healthy

EXPERIMENTAL

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

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

A single dose of dexamethasone IV 4 mg will be administered.

Also known as: Dexamethasone IV
Healthy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Grace Henderson, Study Coordinator
Organization
Vanderbilt University Medical Center
grace.henderson@vumc.org
615-936-5356

Study Officials

  • Katherine N Bachmann, MD

    Vanderbilt Endocrinology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Medicine

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 30, 2017

Study Start

January 1, 2017

Primary Completion

June 8, 2017

Study Completion

January 1, 2018

Last Updated

June 20, 2019

Results First Posted

June 20, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

Locations

US(1)