RECRUITING

Endometriosis and Microvascular Dysfunction: Role of Inflammation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to better understand the underlying mechanisms associated with elevated cardiovascular disease risk in women with endometriosis, and to measure the effectiveness of emerging endometriosis treatments on outcomes specific to cardiovascular dysfunction. 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. The investigators hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is systemic inflammation and activation of LOX-1 receptor mechanisms.

Official Title

Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Endometriosis

Quick Facts

Study Start:2022-01-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05069740

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy women between the ages of 18 and 45 years (Controls), taking oral contraceptive or with regular menses every 26-34 days
  2. * 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)
  3. * Tylenol if the subject has acute pain is allowed
  4. * Contraceptive use is allowed
  1. * Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.)
  2. * Diabetes (HbA1C 6.5%)
  3. * BP\>140/90
  4. * Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications)
  5. * Pregnancy
  6. * Breastfeeding
  7. * Taking illicit and/or recreational drugs
  8. * Abnormal liver function
  9. * Rash, skin disease, disorders of pigmentation, known skin allergies
  10. * Diagnosed or suspected metabolic or cardiovascular disease
  11. * Persistent unexplained elevations of serum transaminases
  12. * Known allergy to latex or investigative substances (including salsalate or simvastatin)
  13. * History of gastrointestinal bleeding

Contacts and Locations

Study Contact

Lacy M Alexander, Ph.D.
CONTACT
8148671781
lma191@psu.edu
Susan Slimak, RN
CONTACT
814-863-8554
sks31@psu.edu

Study Locations (Sites)

The Pennsylvania State University
University Park, Pennsylvania, 16801
United States

Collaborators and Investigators

Sponsor: Penn State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-01-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • skin blood flow
  • inflammation
  • Lectin-like oxidized LDL receptor (LOX-1)
  • intradermal microdialysis

Additional Relevant MeSH Terms

  • Endometriosis