About this trial
This multicenter observational cohort study aims to evaluate whether estimated first-trimester risk of preeclampsia (PE) is associated with subclinical atherosclerosis, cardiovascular risk profile, and cardiovascular events in women with type 1 diabetes (T1D) at least 3 years after pregnancy.
Women with T1D and at least one prior pregnancy with documented first-trimester PE screening will be classified as high or low PE risk according to validated multivariable algorithms. The presence of carotid plaques, cardiometabolic risk factors, and incident cardiovascular events will be assessed during a study visit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Confirmed diagnosis of type 1 diabetes
At least one prior pregnancy with first-trimester preeclampsia screening (<14 weeks gestation)
≥3 years since last pregnancy
Disqualifiers
Previous multiple pregnancy
Cardiovascular disease before pregnancy (coronary heart disease, stroke/TIA, peripheral artery disease, heart failure)
Active pregnancy at time of evaluation
Alcohol or substance dependence (except nicotine/caffeine) in the last 3 years
Trial population
Women with type 1 diabetes followed in endocrinology clinics who had at least one previous pregnancy with documented first-trimester preeclampsia screening.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of carotid plaques
Presence of focal carotid plaque defined as focal wall thickening ≥1.5 mm detected by standardized 2D carotid ultrasound.
Hemoglobin A1c (HbA1c)
HbA1c measured at study visit
Lipid profile
Total cholesterol, triglycerides, HDL-cholesterol and Lipoprotein(a) measured directly. LDL-cholesterol estimated using the Friedewald formula.
Blood pressure
Systolic blood pressure and diastolic blood pressure.
Secondary outcomes
Carotid intima-media thickness
Measured by 2D ultrasonography
Clinical diagnosis of preeclampsia in any pregnancy
Preeclampsia diagnosis will follow the international criteria (Obstet Gynecol. 2020;135(6):e237-e260)
Ambulatory glucose profile (continuous glucose monitoring)
Time-in-range (%), Time-below-range (%), Time-above-range (%), Glucose management indicator (%), Coefficient of variation (%), mean glucose (mg/dL)
Cardiovascular Health Score
Assessed using the American Heart Association (AHA) Life's Essential 8. This score ranges from 0 to 100, with higher values indicating better cardiovascular health.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Lead sponsor
Hospital Mutua de Terrassa
Collaborator
Sociedad Española de Endocrinología y Nutrición
Collaborator
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