CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Dexamethasonedrug
Likely dose
Dexamethasone 4 mg IV, single doseAI-extracted
Key inclusion· 2
  • Age 18–50 years
  • BMI 18.5 to <25 kg/m²
Key exclusion· 10
  • Significant use of systemically-absorbed glucocorticoids currently or within the prior 6 months
  • Current use of antihypertensive medications
  • Current use of metformin or any antidiabetic medications
  • Current use of medications that affect dexamethasone metabolism (phenytoin, rifampin, carbamazepine, troglitazone, barbiturates)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03035929
NCT03035929Phase 1Completed

Diagnosing Natriuretic Peptide Deficiency: A Pilot Study

Vanderbilt University Medical Center·interventional·Posted Jan 30, 2017·Updated Jun 20, 2019

In Brief

A Phase 1 clinical trial evaluating Dexamethasone for Healthy and Lean. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Lean
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 30, 2017
Enrollment StartJan 1, 2017
Primary CompletionJun 8, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.4 years ago

Interventions

Dexamethasonedrug

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