Preeclampsia, Preeclampsia (PE) Risk, Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Preeclampsia, Preeclampsia Risk, Preclinical carotid atherosclerosis, Carotid ultrasonography, Cardiovascular risk, Cardiovascular disease
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.
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).
Interventions
None listed
Sponsors
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Hospital Universitari Mutua Terrassa
Sociedad Española de Endocrinología y Nutrición
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of carotid plaques | 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. |
| Hemoglobin A1c (HbA1c) | At study visit (≥3 years postpartum) | HbA1c measured at study visit |
| Lipid profile | At study visit (≥3 years postpartum) | Total cholesterol, triglycerides, HDL-cholesterol and Lipoprotein(a) measured directly. LDL-cholesterol estimated using the Friedewald formula. |
| Blood pressure | At study visit (≥3 years postpartum) | Systolic blood pressure and diastolic blood pressure. |
| Body mass index | At study visit (≥3 years postpartum) | Calculated as weight (in kg) / height (in meters) \^2 |
| Diabetic-related chronic microvascular complications | From the last pregnancy to the study visit (≥3 years postpartum) | Defined as diabetic retinopathy, chronic kidney disease or diabetic neuropathy |
| Incident cardiovascular events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carotid intima-media thickness | At study visit (≥3 years postpartum) | Measured by 2D ultrasonography |
| Clinical diagnosis of preeclampsia in any pregnancy | At study visit (≥3 years postpartum) | Preeclampsia diagnosis will follow the international criteria (Obstet Gynecol. 2020;135(6):e237-e260) |
| Ambulatory glucose profile (continuous glucose monitoring) | 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) |
| Cardiovascular Health Score | 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. |
| Patient-reported outcomes. Hypoglycemia Fear Survey (HFS) | 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. |
| Patient-reported outcomes. Clarke Score | 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. |
| Patient-reported outcomes. Diabetes Quality of Life questionnaire (DQoL) | 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. |
| Patient-reported outcomes. Pittsburgh Sleep Quality Index (PSQI) | 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. |
| Patient-reported outcomes. Diabetes Distress Scale (DDS) | 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. |
| Patient-reported outcomes. Problem Areas in Diabetes scale (PAID) | 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. |
Countries
Spain
Contacts
CONTACTVerónica Perea, MD, PhD
CONTACTAntonio J. Amor, MD, PhD
Outcome results
None listed