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

Withdrawn

• Conditions: Hypotension; Cirrhosis
• Interventions: Other: serum concentration of estrogen (E1 and E2) and testosterone ratio measurement

• Registration Number: NCT05051293
• Lead Sponsor: Methodist Health System

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 Timeline

• Study Start: 2021-08-22
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Primary Completion: 2022-08-17
• Status Verified: 2023-08
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19
• Study Completion: 2024-08-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Serum estrogen (E1 and E2) levels	July to September 2021	Measurement of serum estrogen (E1 and E2) levels in cirrhotic males
Serum testosterone levels	July to September 2021	Measurement of serum testosterone levels in cirrhotic males

Trial Locations

Locations (1)

Methodist Health System Clinical Research Institute; 🇺🇸 Dallas, Texas, United States