MicroRNA Activation of LOX-1 Mechanisms in Endometriosis

Sponsor

Penn State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05331053

Collaborator

(none)

Enrollment

Location

Arm

104

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Atorvastatin	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Only women with endometriosis will complete this study. Once consented and screened, each subject is asked to take Atorvastatin (Lipitor, 10mg/day) for seven days. Participants will undergo experimental testing before and after the seven day intervention.Only women with endometriosis will complete this study. Once consented and screened, each subject is asked to take Atorvastatin (Lipitor, 10mg/day) for seven days. Participants will undergo experimental testing before and after the seven day intervention.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

MicroRNA Activation of LOX-1 Mechanisms in Endometriosis

Actual Study Start Date :

May 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atorvastatin Oral atorvastatin (Lipitor) therapy (10mg/day) for seven days. Atorvastatin acts as a systemic LOX inhibitor.	Drug: Atorvastatin Simvastation acts as a systemic LOX inhibitor.

Arm

Intervention/Treatment

Experimental: Atorvastatin

Oral atorvastatin (Lipitor) therapy (10mg/day) for seven days. Atorvastatin acts as a systemic LOX inhibitor.

Drug: Atorvastatin

Simvastation acts as a systemic LOX inhibitor.

Outcome Measures

Primary Outcome Measures

Change in skin blood flow [before and after intervention (7 days)]
cutaneous vascular conductance (units = red cell flux/mean arterial pressure)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Pennsylvania State University	University Park	Pennsylvania	United States	16801

Sponsors and Collaborators

Penn State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lacy Alexander, Professor of Kinesiology, Physiology, Penn State University

ClinicalTrials.gov Identifier:

NCT05331053

Other Study ID Numbers:

STUDY00009584

First Posted:

Apr 15, 2022

Last Update Posted:

Apr 15, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lacy Alexander, Professor of Kinesiology, Physiology, Penn State University

Skin blood flow

Cholesterol

Statin

Intradermal Microdialysis

Additional relevant MeSH terms:

Endometriosis

Atorvastatin

Study Results

No Results Posted as of Apr 15, 2022