Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes (PREEATH-T1D)

March 16, 2026 updated by: Antonio J. Amor, Institut d'Investigacions Biomèdiques August Pi i Sunyer

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Preeclampsia (PE) is associated with increased long-term cardiovascular disease (CVD) risk. Women with type 1 diabetes (T1D) are at particularly high risk of both obstetric and cardiovascular complications.

Although clinical PE has been associated with subclinical carotid atherosclerosis and future cardiovascular events in women with T1D, it is unknown whether estimated first-trimester PE risk identifies a subgroup at increased long-term cardiovascular risk, regardless of the development of clinical PE.

Participants will be women with T1D followed in endocrinology clinics across Spain. Eligible participants must have undergone first-trimester PE screening (<14 weeks gestation) in at least one pregnancy and be at least 3 years from their last delivery.

The primary exposure variable is first-trimester estimated PE risk (high vs low). Outcomes include subclinical carotid atherosclerosis, cardiometabolic risk profile, and incident cardiovascular events. Secondary outcomes include glycemic metrics from continuous glucose monitoring, cardiovascular health score (Life's Essential 8), patient-reported outcomes, and the effectiveness of aspirin in preventing clinical PE.

Data will be collected in a single study visit using medical records, physical examination, validated questionnaires, and carotid ultrasound (in centers with availability).

Study Type

Observational

Enrollment (Estimated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
    • Terrassa
      • Terrassa, Terrassa, Spain, 08221
        • Hospital Universitari Mutua Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
High Estimated First-Trimester Preeclampsia Risk
Women with type 1 diabetes classified as high risk for preeclampsia during first-trimester screening in at least one prior pregnancy.
Low Estimated First-Trimester Preeclampsia Risk
Women with type 1 diabetes classified as low risk for preeclampsia during first-trimester screening in at least one prior pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of carotid plaques
Time Frame: At study visit (≥3 years postpartum)
Presence of focal carotid plaque defined as focal wall thickening ≥1.5 mm detected by standardized 2D carotid ultrasound.
At study visit (≥3 years postpartum)
Hemoglobin A1c (HbA1c)
Time Frame: At study visit (≥3 years postpartum)
HbA1c measured at study visit
At study visit (≥3 years postpartum)
Lipid profile
Time Frame: At study visit (≥3 years postpartum)
Total cholesterol, triglycerides, HDL-cholesterol and Lipoprotein(a) measured directly. LDL-cholesterol estimated using the Friedewald formula.
At study visit (≥3 years postpartum)
Blood pressure
Time Frame: At study visit (≥3 years postpartum)
Systolic blood pressure and diastolic blood pressure.
At study visit (≥3 years postpartum)
Body mass index
Time Frame: At study visit (≥3 years postpartum)
Calculated as weight (in kg) / height (in meters) ^2
At study visit (≥3 years postpartum)
Diabetic-related chronic microvascular complications
Time Frame: From the last pregnancy to the study visit (≥3 years postpartum)
Defined as diabetic retinopathy, chronic kidney disease or diabetic neuropathy
From the last pregnancy to the study visit (≥3 years postpartum)
Incident cardiovascular events
Time Frame: From last pregnancy to study visit (minimum 3 years)
Composite of coronary artery disease, cerebrovascular disease, peripheral artery disease, or heart failure occurring between last pregnancy and study evaluation.
From last pregnancy to study visit (minimum 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carotid intima-media thickness
Time Frame: At study visit (≥3 years postpartum)
Measured by 2D ultrasonography
At study visit (≥3 years postpartum)
Clinical diagnosis of preeclampsia in any pregnancy
Time Frame: At study visit (≥3 years postpartum)
Preeclampsia diagnosis will follow the international criteria (Obstet Gynecol. 2020;135(6):e237-e260)
At study visit (≥3 years postpartum)
Ambulatory glucose profile (continuous glucose monitoring)
Time Frame: Three months prior to study visit
Time-in-range (%), Time-below-range (%), Time-above-range (%), Glucose management indicator (%), Coefficient of variation (%), mean glucose (mg/dL)
Three months prior to study visit
Cardiovascular Health Score
Time Frame: At study visit (≥3 years postpartum)
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.
At study visit (≥3 years postpartum)
Patient-reported outcomes. Hypoglycemia Fear Survey (HFS)
Time Frame: At study visit (≥3 years postpartum)
Using the Spanish version of the scale (Tasende C et al. Endocrinol Diabetes Nutr 2018;65:287-296). The score ranges from 24 to 120, with higher values indicating more fear to hypoglycemia.
At study visit (≥3 years postpartum)
Patient-reported outcomes. Clarke Score
Time Frame: At study visit (≥3 years postpartum)
Using the Spanish version of the scale (Jansà M et al. Med Clin 2015;145:511-516). The score ranges from 0 to 7, with higher values indicating less awareness to hypoglycemia.
At study visit (≥3 years postpartum)
Patient-reported outcomes. Diabetes Quality of Life questionnaire (DQoL)
Time Frame: At study visit (≥3 years postpartum)
Using the Spanish version of the scale (Millán MM et al. Endocrinol Nutr. 2002;49:2-8). Higher values indicates better quality of life.
At study visit (≥3 years postpartum)
Patient-reported outcomes. Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At study visit (≥3 years postpartum)
Using the Spanish version of the scale (Royuela A, Macías JA. Psiquis. 1997;18:337-343). The total score ranges from 0 to 21, with a score of 5 or higher indicating poor sleep quality.
At study visit (≥3 years postpartum)
Patient-reported outcomes. Diabetes Distress Scale (DDS)
Time Frame: At study visit (≥3 years postpartum)
Reference: Fisher L et al. J Diabetes Complications 2015;29(4):572-7. Higher scores indicate greater levels of diabetes-related distress.
At study visit (≥3 years postpartum)
Patient-reported outcomes. Problem Areas in Diabetes scale (PAID)
Time Frame: At study visit (≥3 years postpartum)
Using the Spanish version of the scale (Beléndez M et al. Diabetes Research and Clinical Practice. 2014;106: e93-e95). The total score ranges from 0 to 100, with higher scores indicating poor quality of life.
At study visit (≥3 years postpartum)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Collaborators

Hospital Universitari Mutua Terrassa
Sociedad Española de Endocrinología y Nutrición

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 10, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/25-183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to data protection and confidentiality restrictions under the European Union General Data Protection Regulation (EU GDPR 2016/679) and Spanish Organic Law 3/2018 on Personal Data Protection.

Although data collected in this study will be coded, the combination of detailed clinical, obstetric, and cardiovascular variables in a relatively specific population (women with type 1 diabetes and prior pregnancy) may pose a potential risk of re-identification.

Furthermore, participants provide informed consent for use of their data exclusively for the purposes of this research project and related ethically approved analyses. Data sharing beyond these conditions is not covered by the approved consent framework.

Aggregated results will be made publicly available through scientific publications and conference presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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