Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInstitut d'Investigacions Biomèdiques August Pi i Sunyer

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

1,300 Participants
are grouped into 2 trial groups
Group A: High Estimated First-Trimester Preeclampsia Risk
Group B: Low Estimated First-Trimester Preeclampsia Risk

Trial outcomes

Primary outcomes

1

Number of carotid plaques

Presence of focal carotid plaque defined as focal wall thickening ≥1.5 mm detected by standardized 2D carotid ultrasound.

Time frame
At study visit (≥3 years postpartum)
2

Hemoglobin A1c (HbA1c)

HbA1c measured at study visit

Time frame
At study visit (≥3 years postpartum)
3

Lipid profile

Total cholesterol, triglycerides, HDL-cholesterol and Lipoprotein(a) measured directly. LDL-cholesterol estimated using the Friedewald formula.

Time frame
At study visit (≥3 years postpartum)
4

Blood pressure

Systolic blood pressure and diastolic blood pressure.

Time frame
At study visit (≥3 years postpartum)

Secondary outcomes

1

Carotid intima-media thickness

Measured by 2D ultrasonography

Time frame
At study visit (≥3 years postpartum)
2

Clinical diagnosis of preeclampsia in any pregnancy

Preeclampsia diagnosis will follow the international criteria (Obstet Gynecol. 2020;135(6):e237-e260)

Time frame
At study visit (≥3 years postpartum)
3

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)

Time frame
Three months prior to study visit
4

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.

Time frame
At study visit (≥3 years postpartum)

Other outcomes

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

This trial is not recruiting at the moment. You can still explore other options: