Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension Compared to Male Cirrhosis Patients Without Hypotension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Methodist Health System
- Locations
- 1
- Primary Endpoint
- Serum estrogen (E1 and E2) levels
Study Overview
Brief Summary
Cirrhosis is an end stage in liver disease leading to replacement of normal liver tissue with regenerative nodules surrounded by fibrous bands in response to chronic liver injury. It is the eighth leading cause of death in the United States and the thirteenth leading cause of death globally. Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension. The mechanism of hypotension in cirrhosis is thought to be a complex result of the presence of increased level of circulating vasodilators such a nitric oxide coupled with reduced resistance to vasoconstrictors and increased sensitivity to vasodilators.
Detailed Description
Another potential contributor to the development of hypotension in cirrhosis is thought to be due to the increased production of estrogen in males especially the estrone (E1) and estradiol (E2) concentration. The concentration of estrogen in cirrhotic patients is thought to increase by fourfold compared to individuals without cirrhosis. The increased estrogen concentration in cirrhosis patients results, in large part, from an increased peripheral conversion from androgens including testosterone. Previous studies have shown that increased estrogen concentration can cause a significant decrease in blood pressure in various cell, animal, and human models. Of note, estrogen has also been shown to enhance nitric oxide production in human beings.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male cirrhotic patients >18 years of age
- •Patient must attend the outpatient clinic of the Liver Institute at Methodist Dallas Medical Center
- •willing to provide informed consent to participate in the study
Exclusion Criteria
- •Patients with a history of cirrhosis <18 years of age
- •Cirrhosis patients with active infection
- •Cirrhosis patients with active gastrointestinal bleeding
- •Cirrhosis patients on hormone replacement therapy testosterone
- •Cirrhosis patients on any antihypertensive medications
Arms & Interventions
male cirrhotic with hypotension
Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension.
Intervention: serum concentration of estrogen (E1 and E2) and testosterone ratio measurement (Other)
male cirrhotic without hypotension
The concentration of estrogen in cirrhotic patients is thought to increase by fourfold compared to individuals without cirrhosis.
Intervention: serum concentration of estrogen (E1 and E2) and testosterone ratio measurement (Other)
Outcomes
Primary Outcomes
Serum estrogen (E1 and E2) levels
Time Frame: July to September 2021
Measurement of serum estrogen (E1 and E2) levels in cirrhotic males
Serum testosterone levels
Time Frame: July to September 2021
Measurement of serum testosterone levels in cirrhotic males
Secondary Outcomes
No secondary outcomes reported