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Pregnancy warning sign may flag heart risk in type 1 diabetes

NCT ID NCT07479329

Knowledge-focused Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow 1300 women with type 1 diabetes who had a pregnancy. Researchers want to see if a high risk of preeclampsia (a dangerous pregnancy complication) in the first trimester is linked to hidden heart disease years later. Participants will have an ultrasound to check for plaque in their neck arteries and other heart health tests. The goal is to better understand long-term risks, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify women with type 1 diabetes who are at higher risk for heart problems after pregnancy, leading to earlier monitoring or prevention.
What could go wrong
This is an observational study, not a treatment trial. It will only show links, not cause and effect. Results may take years and might not change care directly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women with type 1 diabetes followed in endocrinology clinics who had at least one previous pregnancy with documented first-trimester preeclampsia screening.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder preeclampsia type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Preeclampsia Preeclampsia (PE) risk Type 1 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clínic Barcelona

    Barcelona, Barcelona, 08036, Spain

  • Hospital Universitari Mútua Terrassa

    Terrassa, Terrassa, 08221, Spain

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