Healthy, Lean
Conditions
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
Interventions
DRUGDexamethasone
A single dose of dexamethasone IV 4 mg will be administered.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in NT-proANP From Baseline to 8 Hours | baseline and 8 hours | Change in natriuretic peptide levels after drug administration |
| Changes in NT-proBNP From Baseline to 8 Hours | Baseline and 8 hours | Change in natriuretic peptide levels after drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in NT-proANP | baseline, 24 hours, 48 hours and 72 hours | Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours |
| Changes in NT-proBNP | at baseline, 24 hours, 48 hours and 72 hours | Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours |
| BNP (B-type Natriuretic Peptide) | 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration | Natriuretic peptide levels after drug administration |
| ANP (Atrial Natriuretic Peptide) | 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration | Natriuretic peptide levels after drug administration |
Countries
United States
Participant flow
Pre-assignment details
1 participant withdrew after consent but before the baseline visit and is not included in the results.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.
All subjects will undergo the same procedures and interventions.
Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Healthy |
|---|---|
| Age, Continuous | 27.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Changes in NT-proANP From Baseline to 8 Hours
Change in natriuretic peptide levels after drug administration
Time frame: baseline and 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy | Changes in NT-proANP From Baseline to 8 Hours | -0.33 nmol/l | Standard Deviation 0.25 |
Primary
Changes in NT-proBNP From Baseline to 8 Hours
Change in natriuretic peptide levels after drug administration
Time frame: Baseline and 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy | Changes in NT-proBNP From Baseline to 8 Hours | 18.4 pg/ml | Standard Deviation 20.3 |
Secondary
ANP (Atrial Natriuretic Peptide)
Natriuretic peptide levels after drug administration
Time frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
Population: Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.
Secondary
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
Population: Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy | Changes in NT-proANP | Change from baseline to 24 hours | -0.23 nmol/l | Standard Deviation 0.22 |
| Healthy | Changes in NT-proANP | Change from baseline to 48 hours | 0.17 nmol/l | Standard Deviation 0.36 |
| Healthy | Changes in NT-proANP | Change from baseline to 72 hours | -0.05 nmol/l | Standard Deviation 0.33 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy | Changes in NT-proBNP | Change from baseline to 24 hours | -5.0 pg/ml | Standard Deviation 26.9 |
| Healthy | Changes in NT-proBNP | Change from baseline to 48 hours | -23.4 pg/ml | Standard Deviation 41.4 |
| Healthy | Changes in NT-proBNP | Change from baseline to 72 hours | -16.9 pg/ml | Standard Deviation 39.6 |