Study of the Effect of Testosterone and Estradiol on NP Responses to Acute and Chronic Salt Loading

Withdrawn before enrolling · Early Phase 1

Conditions studied: Hypertension

In brief

There is gender dimorphism in cardiovascular risk, with men at higher risk than women. However, the fundamental basis for the protective effect of female sex remains unclear. Recent data implicate the natriuretic peptide (NP) system as an important determinant of blood pressure. Also, NP levels are twice as high in women of reproductive age than in men, and gonadal steroids are important determinants of circulating NPs. These are the marked, but poorly understood differences in the NP status between men and women. The investigators hypothesize that gonadal steroids regulate NP release, specifically that testosterone inhibits and estrogen activates the NP axis, leading to differences in both resting NP levels and dynamic responses of the NP, RAAS, and kidneys to acute and chronic salt loading. Understanding the basis for gender differences in NP function should provide important insights regarding mechanisms underlying hypertension in men versus women.

Key facts

Study ID

NCT01763541

Run by

Massachusetts General Hospital

People needed

0

Starts

2014-06-01

Expected to finish

2016-02-01

Last updated by the study team

2017-10-19

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18-40 years old
• no history of hypertension
• normal BMI
• Male: normal testosterone and free testosterone levels
• Female: regular menses, negative pregnancy test, no sex steroid therapy >/=3 mos

You may not qualify if…

• on hypertensives, diuretics, or insulin
• with diabetes mellitus
• estimated creatinine clearance <60 ml/min
• prior cardiovascular, liver or renal disease
• history of hormonally-responsive cancer
• elevated liver function test (LFTs)
• atrial fibrillation
• abnormal sodium or potassium levels
• taking medications that directly impact the endocrine system (exogenous hormones, steroids, etc.)
• taking medications that indirectly impact the endocrine system (SSRIs, opioids, finasteride, etc.)
• with untreated hyper- or hypothyroidism
• smoker
• psychiatric history
• Women: not willing to abstain from getting pregnant during the course of the study, with abnormal menstrual cycle, or who have osteoporosis
• Men: with polycythemia

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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