Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,300
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c (HbA1c)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Hemoglobin A1c (HbA1c)
时间窗: At study visit (≥3 years postpartum)
HbA1c measured at study visit
Number of carotid plaques
时间窗: 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.
Lipid profile
时间窗: 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
时间窗: At study visit (≥3 years postpartum)
Systolic blood pressure and diastolic blood pressure.
Body mass index
时间窗: At study visit (≥3 years postpartum)
Calculated as weight (in kg) / height (in meters) \^2
Diabetic-related chronic microvascular complications
时间窗: From the last pregnancy to the study visit (≥3 years postpartum)
Defined as diabetic retinopathy, chronic kidney disease or diabetic neuropathy
Incident cardiovascular events
时间窗: 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.
次要结局
- 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))
- Patient-reported outcomes. Clarke Score(At study visit (≥3 years postpartum))
- Patient-reported outcomes. Diabetes Quality of Life questionnaire (DQoL)(At study visit (≥3 years postpartum))
- Patient-reported outcomes. Pittsburgh Sleep Quality Index (PSQI)(At study visit (≥3 years postpartum))
- Patient-reported outcomes. Diabetes Distress Scale (DDS)(At study visit (≥3 years postpartum))
- Patient-reported outcomes. Problem Areas in Diabetes scale (PAID)(At study visit (≥3 years postpartum))
研究者
Antonio J. Amor
Principal Investigator
Institut d'Investigacions Biomèdiques August Pi i Sunyer