Trials / Withdrawn
WithdrawnNCT05051293
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- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Methodist Health System · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-08-22
- Primary completion
- 2022-08-17
- Completion
- 2024-08-17
- First posted
- 2021-09-21
- Last updated
- 2026-03-24
Source: ClinicalTrials.gov record NCT05051293. Inclusion in this directory is not an endorsement.