Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Mutua de Terrassa | OTHER |
| Sociedad Española de Endocrinología y Nutrición | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Carotid intima-media thickness | Measured by 2D ultrasonography | At study visit (≥3 years postpartum) |
| Clinical diagnosis of preeclampsia in any pregnancy | Preeclampsia diagnosis will follow the international criteria (Obstet Gynecol. 2020;135(6):e237-e260) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Women with type 1 diabetes followed in endocrinology clinics who had at least one previous pregnancy with documented first-trimester preeclampsia screening.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Verónica Perea, MD, PhD | Contact | +34 93 736 50 50 | vperea@mutuaterrassa.cat | |
| Antonio J. Amor, MD, PhD | Contact | +34932279846 | ajamor@clinic.cat |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic Barcelona | Barcelona | Barcelona | 08036 | Spain | ||
| Hospital Universitari Mútua Terrassa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40205402 | Background | 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. | |
| 38149646 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| At study visit (≥3 years postpartum) |
| Ambulatory glucose profile (continuous glucose monitoring) | 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 | 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) | 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 | 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) | 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) | 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) | 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) | 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) |
| Terrassa |
| Terrassa |
| 08221 |
| Spain |
| 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. |
| 34663538 | Background | 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. |
| 33238177 | Background | 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. |
| 32515046 | Background | 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. |
| 31529047 | Background | 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. |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D011225 | Pre-Eclampsia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided