Clinical trial NCT03035929: Diagnosing Natriuretic Peptide Deficiency
Official title: Diagnosing Natriuretic Peptide Deficiency: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lean
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: see above

Eligibility criteria: Inclusion criteria:

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

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

Primary outcomes:
measure: Changes in NT-proANP From Baseline to 8 Hours
timeFrame: baseline and 8 hours
measure: Changes in NT-proBNP From Baseline to 8 Hours
timeFrame: Baseline and 8 hours
Secondary outcomes:
measure: Changes in NT-proANP
timeFrame: baseline, 24 hours, 48 hours and 72 hours
measure: Changes in NT-proBNP
timeFrame: at baseline, 24 hours, 48 hours and 72 hours
measure: BNP (B-type Natriuretic Peptide)
timeFrame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
measure: ANP (Atrial Natriuretic Peptide)
timeFrame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt Endocrinology
name: Katherine N Bachmann, MD
role: PRINCIPAL_INVESTIGATOR
References: