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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cirrhosis; Hypotension
• Intervention / Treatment: Other: serum concentration of estrogen (E1 and E2) and testosterone ratio measurement

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Health System Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male patients attending the outpatient clinic of the Liver Institute at Methodist Dallas Medical Center, Dallas, Texas

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
male cirrhotic with hypotension; Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension.	Other: serum 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
male cirrhotic without hypotension; The concentration of estrogen in cirrhotic patients is thought to increase by fourfold compared to individuals without cirrhosis.	Other: serum 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum estrogen (E1 and E2) levels	Measurement of serum estrogen (E1 and E2) levels in cirrhotic males	July to September 2021
Serum testosterone levels	Measurement of serum testosterone levels in cirrhotic males	July to September 2021

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Mangesh Pagadala, MD, Methodist

Publications and helpful links

General Publications

• Ge PS, Runyon BA. Treatment of Patients with Cirrhosis. N Engl J Med. 2016 Nov 24;375(21):2104-5. doi: 10.1056/NEJMc1612334. No abstract available.
• Iwakiri Y, Groszmann RJ. The hyperdynamic circulation of chronic liver diseases: from the patient to the molecule. Hepatology. 2006 Feb;43(2 Suppl 1):S121-31. doi: 10.1002/hep.20993.
• Cavanaugh J, Niewoehner CB, Nuttall FQ. Gynecomastia and cirrhosis of the liver. Arch Intern Med. 1990 Mar;150(3):563-5.
• Gordon GG, Olivo J, Rafil F, Southren AL. Conversion of androgens to estrogens in cirrhosis of the liver. J Clin Endocrinol Metab. 1975 Jun;40(6):1018-26. doi: 10.1210/jcem-40-6-1018.
• Seely EW, Walsh BW, Gerhard MD, Williams GH. Estradiol with or without progesterone and ambulatory blood pressure in postmenopausal women. Hypertension. 1999 May;33(5):1190-4. doi: 10.1161/01.hyp.33.5.1190.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2021
• Primary Completion (Actual): August 17, 2022
• Study Completion (Estimated): August 17, 2024

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis; Hypotension; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; methyl N-acetylsibirosaminide
• Other Study ID Numbers: 097.HEP.2020.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No