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Not yet recruiting NCT07479329

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

— Observational Type 1 Diabetes Preeclampsia Preeclampsia (PE) Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Type 1 Diabetes, Preeclampsia, Preeclampsia (PE) Risk. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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).

Primary outcome measures

  • Number of carotid plaques [Time frame: At study visit (≥3 years postpartum)]
  • Hemoglobin A1c (HbA1c) [Time frame: At study visit (≥3 years postpartum)]
  • Lipid profile [Time frame: At study visit (≥3 years postpartum)]
  • Blood pressure [Time frame: At study visit (≥3 years postpartum)]
  • Body mass index [Time frame: At study visit (≥3 years postpartum)]
  • Diabetic-related chronic microvascular complications [Time frame: 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)]
Secondary outcome measures (10)
  • Carotid intima-media thickness [Time frame: At study visit (≥3 years postpartum)]
  • Clinical diagnosis of preeclampsia in any pregnancy [Time frame: At study visit (≥3 years postpartum)]
  • Ambulatory glucose profile (continuous glucose monitoring) [Time frame: Three months prior to study visit]
  • Cardiovascular Health Score [Time frame: At study visit (≥3 years postpartum)]
  • Patient-reported outcomes. Hypoglycemia Fear Survey (HFS) [Time frame: At study visit (≥3 years postpartum)]
  • Patient-reported outcomes. Clarke Score [Time frame: At study visit (≥3 years postpartum)]
  • Patient-reported outcomes. Diabetes Quality of Life questionnaire (DQoL) [Time frame: At study visit (≥3 years postpartum)]
  • Patient-reported outcomes. Pittsburgh Sleep Quality Index (PSQI) [Time frame: At study visit (≥3 years postpartum)]
  • Patient-reported outcomes. Diabetes Distress Scale (DDS) [Time frame: At study visit (≥3 years postpartum)]
  • Patient-reported outcomes. Problem Areas in Diabetes scale (PAID) [Time frame: At study visit (≥3 years postpartum)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 2 centers
  • Hospital Clínic Barcelona — Barcelona
  • Hospital Universitari Mútua Terrassa — Terrassa

Publications

  • 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 40205402
  • 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 38149646
  • 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 34663538
  • 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 33238177
  • 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 32515046
  • 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 31529047

Identifiers

NCT: NCT07479329 · P/25-183

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗