Endometriosis and Microvascular Dysfunction: Role of Inflammation
ConditionEndometriosis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorPenn State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy women between the ages of 18 and 45 years (Controls), taking oral contraceptive or with regular menses every 26-34 days
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)
Tylenol if the subject has acute pain is allowed
Contraceptive use is allowed
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Salsalate Pill
DrugSalsalate acts as an NFkB inhibitor to reduce systemic inflammation
Placebo
DrugPlacebo for the salsalate intervention
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: SalsalateExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
cutaneous vascular conductance
doppler flowmetry used to measure cutaneous vascular conductance (cvc = red cell flux/mean arterial pressure) to assess microvascular endothelial function
Time frame
5 days after treatment2
brachial artery diameter and blood flow velocity
continuous ultrasound imaging measurements of brachial artery diameter and blood flow velocity to assess endothelial function
Time frame
5 days after treatment3
Sera LOX-1 protein expression
Peripheral Blood Mononuclear Cell Isolation, LOX-1 expression quantified using real time pCR
Time frame
5 days after treatment4
Biopsy LOX-1 protein expression
Bio-Rad DC assay, western blot technique used for LOX-1 protein receptor expression
Time frame
5 days after treatmentSecondary outcomes
1
sera reproductive hormone analysis
analysis of plasma estradiol, progesterone, and sex hormone binding globulin determined through hormone assay
Time frame
5 days after treatment2
sera cytokine expression analysis
expression of cytokines CRP, TNF-a, IL-1B, IL-6, IL-8 determined through multiplex assay
Time frame
5 days after treatment3
skin biopsy biochemical analysis
the expression of estrogen receptor alpha and beta, the protein pVASP/VASP, and the enzyme peNOS/eNOS is determined using Bio-Rad DC assay, western blot technique
Time frame
5 days after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov