Diagnosing Natriuretic Peptide Deficiency

NCT ID: NCT03035929

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-01-01

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

Conditions

Healthy; Lean

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy

10 Healthy subjects will undergo study procedures at four study visits.

All subjects will undergo the same procedures and interventions.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

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

Interventions

Dexamethasone

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

Intervention Type: DRUG

Other Intervention Names

Dexamethasone IV

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Katherine N. Bachmann, MD

Instructor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine N Bachmann, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Endocrinology

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

161482

Identifier Type: -

Identifier Source: org_study_id