Trials / Completed
CompletedNCT02951949
Estrogen Exposure and Atherosclerosis in Postmenopausal Women
Exposure to Endogenous Estrogens and Imaging Parameters of Atherosclerosis Burden in Postmenopausal Women
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 92 (actual)
- Sponsor
- University of Valencia · Academic / Other
- Sex
- Female
- Age
- 45 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
One hundred Spanish postmenopausal women accepted to be investigated for cardiovascular risk actors including clinical features, serum biochemical parameters, single nucleotide polymorphisms for estrogen receptor, and imaging parameters, carotid intima-media thickness (91 women) and coronary computed tomography (32 women). Multivariable analysis confirmed that both age and glucose level directly affected IMT. Estrogenic exposure, as measured by the allele associated with lower expression of the ER beta gene, was protective at the sinus and the wall. Findings at the coronary arteries, either moderate or high calcium index (CAC) and/or significant lumen stenosis were sporadic and did not allow for establishing association with any of the variables assessed.
Detailed description
One hundred postmenopausal women living in the urban area of Valencia were invited to participate in a cross-sectional study in which a list of clinical and analytical risk factors for cardiovascular disease were assessed. Clinical factors included weight, waist circumference, body mass index and blood pressure. Analytical parameters included lipidogram, serum glucose and insulin, thyroid hormones (TSH and total T4), vitamin D, ultra-sensitive C-reactive protein, estradiol, and osteoprotegerin. Imaging studies were performed to identify the atherosclerotic burden at the carotid artery (intima-media thickness, measured by a high frequency ultrasound probe), and the coronaries (both coronary artery calcium(CAC) score and the degree of lumen stenosis). Genetic susceptibility was measured by studying single nucleotide polymorphisms of the estrogen receptor. The independent effect of each variable was analyzed with multivariate analysis.
Conditions
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2015-07-01
- Completion
- 2015-12-01
- First posted
- 2016-11-01
- Last updated
- 2020-04-07
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT02951949. Inclusion in this directory is not an endorsement.