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Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension

M

Methodist Health System

Status

Withdrawn

Conditions

Hypotension
Cirrhosis

Treatments

Other: serum concentration of estrogen (E1 and E2) and testosterone ratio measurement

Study type

Observational

Funder types

Other

Identifiers

NCT05051293
097.HEP.2020.D

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

male cirrhotic with hypotension
Description:
Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension.
Treatment:
Other: serum concentration of estrogen (E1 and E2) and testosterone ratio measurement
male cirrhotic without hypotension
Description:
The concentration of estrogen in cirrhotic patients is thought to increase by fourfold compared to individuals without cirrhosis.
Treatment:
Other: serum concentration of estrogen (E1 and E2) and testosterone ratio measurement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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