NCT07479329

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Apr 2026Apr 2028

First Submitted

Initial submission to the registry

March 3, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

March 3, 2026

Last Update Submit

March 16, 2026

Conditions

Type 1 DiabetesPreeclampsiaPreeclampsia (PE) Risk

Keywords

Type 1 DiabetesPreeclampsiaPreeclampsia RiskPreclinical carotid atherosclerosisCarotid ultrasonographyCardiovascular riskCardiovascular disease

Outcome Measures

Primary Outcomes (7)

  • Number of carotid plaques

    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)

    HbA1c measured at study visit

    At study visit (≥3 years postpartum)

  • Lipid profile

    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

    Systolic blood pressure and diastolic blood pressure.

    At study visit (≥3 years postpartum)

  • Body mass index

    Calculated as weight (in kg) / height (in meters) \^2

    At study visit (≥3 years postpartum)

  • Diabetic-related chronic microvascular complications

    Defined as diabetic retinopathy, chronic kidney disease or diabetic neuropathy

    From the last pregnancy to the study visit (≥3 years postpartum)

  • Incident cardiovascular events

    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 Outcomes (10)

  • Carotid intima-media thickness

    At study visit (≥3 years postpartum)

  • Clinical diagnosis of preeclampsia in any pregnancy

    At study visit (≥3 years postpartum)

  • Ambulatory glucose profile (continuous glucose monitoring)

    Three months prior to study visit

  • Cardiovascular Health Score

    At study visit (≥3 years postpartum)

  • Patient-reported outcomes. Hypoglycemia Fear Survey (HFS)

    At study visit (≥3 years postpartum)

  • +5 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Clínic Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitari Mútua Terrassa

Terrassa, Terrassa, 08221, Spain

Location

Related Publications (6)

  • Mesa A, Puig-Jove C, Pane A, Vinagre I, Lopez-Quesada E, Meler E, Alonso-Carril N, Quiros C, Amor AJ, Perea V. Preeclampsia as an independent predictor of atherosclerosis progression in women with type 1 diabetes: a 5-year prospective study. Cardiovasc Diabetol. 2025 Apr 9;24(1):160. doi: 10.1186/s12933-025-02719-3.

    PMID: 40205402BACKGROUND

  • Perea V, Vinagre I, Seres-Noriega T, Vinals C, Mesa A, Pane A, Milad C, Esmatjes E, Conget I, Gimenez M, Amor AJ. Impact of Preeclampsia and Parity on Sex-based Discrepancies in Subclinical Carotid Atherosclerosis in Type 1 Diabetes. J Clin Endocrinol Metab. 2024 Aug 13;109(9):e1759-e1767. doi: 10.1210/clinem/dgad755.

    PMID: 38149646BACKGROUND

  • Amor AJ, Vinagre I, Valverde M, Alonso N, Urquizu X, Meler E, Lopez E, Gimenez M, Codina L, Conget I, Barahona MJ, Perea V. Novel glycoproteins identify preclinical atherosclerosis among women with previous preeclampsia regardless of type 1 diabetes status. Nutr Metab Cardiovasc Dis. 2021 Nov 29;31(12):3407-3414. doi: 10.1016/j.numecd.2021.08.041. Epub 2021 Aug 26.

    PMID: 34663538BACKGROUND

  • Amor AJ, Vinagre I, Valverde M, Urquizu X, Meler E, Lopez E, Alonso N, Pane A, Gimenez M, Codina L, Conget I, Barahona MJ, Perea V. Nuclear magnetic resonance-based metabolomic analysis in the assessment of preclinical atherosclerosis in type 1 diabetes and preeclampsia. Diabetes Res Clin Pract. 2021 Jan;171:108548. doi: 10.1016/j.diabres.2020.108548. Epub 2020 Nov 22.

    PMID: 33238177BACKGROUND

  • Amor AJ, Vinagre I, Valverde M, Urquizu X, Meler E, Lopez E, Quiros C, Gimenez M, Codina L, Conget I, Barahona MJ, Perea V. Nuclear magnetic resonance lipoproteins are associated with carotid atherosclerosis in type 1 diabetes and pre-eclampsia. Diabetes Metab Res Rev. 2021 Jan;37(1):e3362. doi: 10.1002/dmrr.3362. Epub 2020 Jul 2.

    PMID: 32515046BACKGROUND

  • Amor AJ, Vinagre I, Valverde M, Pane A, Urquizu X, Meler E, Lopez E, Quiros C, Gimenez M, Codina L, Conget I, Barahona MJ, Perea V. Preeclampsia Is Associated With Increased Preclinical Carotid Atherosclerosis in Women With Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz031. doi: 10.1210/clinem/dgz031.

    PMID: 31529047BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Pre-EclampsiaCardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Verónica Perea, MD, PhD

CONTACT

+34 93 736 50 50vperea@mutuaterrassa.cat

Antonio J. Amor, MD, PhD

CONTACT

+34932279846ajamor@clinic.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 18, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(2)