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

Обзор

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.

Подробное описание

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).

Первичные конечные точки

• Number of carotid plaques [Срок оценки: At study visit (≥3 years postpartum)]
• Hemoglobin A1c (HbA1c) [Срок оценки: At study visit (≥3 years postpartum)]
• Lipid profile [Срок оценки: At study visit (≥3 years postpartum)]
• Blood pressure [Срок оценки: At study visit (≥3 years postpartum)]
• Body mass index [Срок оценки: At study visit (≥3 years postpartum)]
• Diabetic-related chronic microvascular complications [Срок оценки: From the last pregnancy to the study visit (≥3 years postpartum)]
• Incident cardiovascular events [Срок оценки: From last pregnancy to study visit (minimum 3 years)]

Вторичные конечные точки (10)

• Carotid intima-media thickness [Срок оценки: At study visit (≥3 years postpartum)]
• Clinical diagnosis of preeclampsia in any pregnancy [Срок оценки: At study visit (≥3 years postpartum)]
• Ambulatory glucose profile (continuous glucose monitoring) [Срок оценки: Three months prior to study visit]
• Cardiovascular Health Score [Срок оценки: At study visit (≥3 years postpartum)]
• Patient-reported outcomes. Hypoglycemia Fear Survey (HFS) [Срок оценки: At study visit (≥3 years postpartum)]
• Patient-reported outcomes. Clarke Score [Срок оценки: At study visit (≥3 years postpartum)]
• Patient-reported outcomes. Diabetes Quality of Life questionnaire (DQoL) [Срок оценки: At study visit (≥3 years postpartum)]
• Patient-reported outcomes. Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: At study visit (≥3 years postpartum)]
• Patient-reported outcomes. Diabetes Distress Scale (DDS) [Срок оценки: At study visit (≥3 years postpartum)]
• Patient-reported outcomes. Problem Areas in Diabetes scale (PAID) [Срок оценки: At study visit (≥3 years postpartum)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 2 центра

• Hospital Clínic Barcelona — Barcelona
• Hospital Universitari Mútua Terrassa — Terrassa

Публикации

• 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

Идентификаторы

NCT: NCT07479329 · P/25-183

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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