Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT03397966
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03397966
Study Brief:
Protocol Section:
NCT03397966