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

Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension Compared to Male Cirrhosis Patients Without Hypotension

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05051293
Enrollment
0
Registered
2021-09-21
Start date
2021-08-22
Completion date
2024-08-17
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Hypotension

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.

Interventions

OTHERserum concentration of estrogen (E1 and E2) and testosterone ratio measurement

To measure the serum concentration of estrogen (E1 and E2) and testosterone ratio in all male cirrhosis patients

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Serum estrogen (E1 and E2) levelsJuly to September 2021Measurement of serum estrogen (E1 and E2) levels in cirrhotic males
Serum testosterone levelsJuly to September 2021Measurement of serum testosterone levels in cirrhotic males

Contacts

PRINCIPAL_INVESTIGATORMangesh Pagadala, MD

Methodist

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026