Status:
TERMINATED
Metabolic Effects of Natriuretic Peptide Hormones
Lead Sponsor:
VA Office of Research and Development
Conditions:
Obesity
Cardiovascular Physiological Phenomena
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
Brief Summary
Accumulating evidence suggests that the natriuretic peptide (NP) hormonal system has important effects on metabolism. However, more information is needed to better understand the effects of NPs on met...
Detailed Description
Objective: The natriuretic peptide (NP) hormonal system is well-known for its important role in blood pressure regulation. However, accumulating evidence suggests that the NPs have significant effects...
Eligibility Criteria
Inclusion
- Men and women ages 18-40 years
- Body Mass Index (BMI): 18.5 BMI\<25 kg/m2 (lean) or BMI \> or = 30 kg/m2 (obese)
Exclusion
- Significant cardiovascular disease (including heart failure and atrial fibrillation)
- Significant pulmonary, liver, or renal disease
- Diabetes Mellitus
- Significant Hypertension
- Hypotension
- Thyroid dysfunction
- Active malignancy
- Current or recent use of glucocorticoids
- Current use of antihypertensive medications, including diuretics
- Current use of medications affecting glucose metabolism, including metformin
- Current use of amphetamines or other medications known to affect energy homeostasis
- Currently pregnant or breastfeeding, or unwilling to avoid becoming pregnant or breastfeeding during study duration
- Significant claustrophobia that would prevent the use of the metabolic cart as part of the study protocol
- Currently abnormal serum or plasma sodium or potassium level
- Known hypersensitivity to recombinant human b-type natriuretic peptide, BNP(1-32) (nesiritide), or phenylephrine
- Hemoglobin A1c (HbA1c) \>= 6.5%
- Liver Function Tests (LFTs) elevated \>2x upper limit of normal
- Estimated Glomerular Filtration Rate (eGFR) \<60 ml/min
- Currently abnormal thyroid stimulating hormone (TSH)
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03397966
Start Date
July 1 2018
End Date
May 1 2019
Last Update
November 25 2024
Active Locations (2)
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1
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232