Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

Preeclampsia risk in early pregnancy and long-term heart health in women with type 1 diabetes

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

Run by Institut d'Investigacions Biomèdiques August Pi i Sunyer · NCT07479329 · Data updated 2026-11-12

We’re testing whether a high estimated risk of preeclampsia in the first trimester is linked to hidden heart and blood vessel changes and future cardiovascular problems in women with type 1 diabetes.

More Type 1 Diabetes trials

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment1300 (estimated)
SponsorInstitut d'Investigacions Biomèdiques August Pi i Sunyer
Academic / other
Locations2 sites (Barcelona, Barcelona and 1 other locations)
StatusRecruiting
StartedApril 10, 2026
Main results expectedApril 30, 2028
Study endsApril 30, 2028
Registry record updatedNovember 5, 2026
Trial IDNCT07479329 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women with type 1 diabetes, at least one prior pregnancy with first-trimester PE screening, and at least 3 years since last delivery.

Probably not a fit

Women without previously screened first-trimester PE data or those outside the 3-year post-pregnancy window may see limited relevance.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter observational study in Spain that looks at adults with type 1 diabetes who had at least one pregnancy and a first-trimester preeclampsia screen. Researchers classify participants as high or low risk for preeclampsia and examine carotid artery health, metabolic risk factors, and any cardiovascular events years after delivery. Data are collected during a single study visit through medical records, exams, questionnaires, and carotid ultrasound where available. The study also explores glycemic metrics from continuous glucose monitoring and the potential protective role of aspirin against clinical preeclampsia. Overall, the goal is to understand if early pregnancy risk signals long-term cardiovascular risk beyond the occurrence of PE itself.

Why it matters

Potential benefit: If successful, it could help identify women with T1D at higher long-term cardiovascular risk so they can receive targeted monitoring and preventive care.

How similar studies have gone: Prior work links clinical preeclampsia to future cardiovascular risk in women with T1D, but this study tests whether estimated PE risk in the first trimester identifies a high-risk subgroup.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Active severe psychiatric disease, dementia, severe disability, or reduced life expectancy

Where it's running

  • Hospital Clínic Barcelona
    Barcelona, Barcelona, Spain
    Recruiting
  • Hospital Universitari Mútua Terrassa
    Terrassa, Terrassa, Spain
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.