MicroRNA Activation of LOX-1 Mechanisms in Endometriosis

Endometriosis Clinical Trial

Official title:

MicroRNA Activation of LOX-1 Mechanisms in Endometriosis

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05331053
• Other study ID #: STUDY00009584
• Status: Suspended
• Phase: Phase 4
• Start date: May 1, 2018
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endometriosis is a disorder that occurs in women. With endometriosis, tissue that should be found in the womb is found in sites outside of the womb. This disorder impairs the function of the cells that line the body's blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with this disorder have an increased risk for high blood pressure and high cholesterol. They have a higher risk for cardiovascular disease, too. With this study, we will learn how endometriosis impairs the lining of blood vessels and increases the risk for disease.

Description:

Epidemiologic data demonstrate a clear association between endometriosis, reproductive risk factors, inflammation and cardiovascular (CV) risk. Circulating factors, Low-density lipoprotein (LDL) and oxidized LDL (oxLDL), are two of many biomarkers of cardiovascular and inflammatory disease of endometriosis. An important signaling mechanism through which circulating LDL and oxLDL act is the lectin-like oxidized LDL receptor (LOX-1). LOX-1 signal transduction functionally results in pronounced endothelial dysfunction, a hallmark of CV. We hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is microRNA (miRNA) activation of LOX-1 receptor mechanisms.

Specific Aim 1. To test the hypothesis that LOX-1 receptor activation is increased leading to endothelial dysfunction in endometriosis.

Specific Aim 2. To test the hypothesis that decreased microRNAs (i.e. let7-a, let7-b, let7-g, MiR98, Mi590-p) are driving increased LOX-1 receptor expression and function in endometriosis.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 6
• Est. completion date: August 31, 2024
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician <5 years prior, and reported by the subject to the researchers)

Exclusion Criteria:

• Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.)

• Diabetes (HbA1C .6.5%)

• BP>140/90

• Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications)

• Pregnancy

• Breastfeeding

• Taking illicit and/or recreational drugs

• Abnormal liver function

• Rash, skin disease, disorders of pigmentation, known skin allergies

• Diagnosed or suspected metabolic or cardiovascular disease

• Persistent unexplained elevations of serum transaminases

• Known allergy to latex or investigative substances

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Atorvastatin
Simvastation acts as a systemic LOX inhibitor.

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Nitric Oxide Dependent Vasodilation in the Skin	area under the curve of laser Doppler flux/mean arterial pressure * log acetylcholine (mol/L)	before and after intervention (7 days)