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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05051293
• Other study ID #: 097.HEP.2020.D
• Status: Withdrawn
• Start date: August 22, 2021
• Est. completion date: August 17, 2024

Study information

• Verified date: August 2023
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 17, 2024
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hypotension
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
United States	Methodist Health System Clinical Research Institute	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

References & Publications (5)

Cavanaugh J, Niewoehner CB, Nuttall FQ. Gynecomastia and cirrhosis of the liver. Arch Intern Med. 1990 Mar;150(3):563-5. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum estrogen (E1 and E2) levels	Measurement of serum estrogen (E1 and E2) levels in cirrhotic males	July to September 2021
Primary	Serum testosterone levels	Measurement of serum testosterone levels in cirrhotic males	July to September 2021