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NCT Number: NCT07479329

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension, Pregnancy-Induced Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pre-Eclampsia Preeclampsia Preeclampsia (PE) Risk Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Clínic Barcelona, Barcelona, Spain

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of carotid plaques

    Time frame: 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.

  2. Hemoglobin A1c (HbA1c)

    Time frame: At study visit (≥3 years postpartum)

    HbA1c measured at study visit

  3. Lipid profile

    Time frame: At study visit (≥3 years postpartum)

    Total cholesterol, triglycerides, HDL-cholesterol and Lipoprotein(a) measured directly. LDL-cholesterol estimated using the Friedewald formula.

  4. Blood pressure

    Time frame: At study visit (≥3 years postpartum)

    Systolic blood pressure and diastolic blood pressure.

  5. Body mass index

    Time frame: At study visit (≥3 years postpartum)

    Calculated as weight (in kg) / height (in meters) ^2

  6. Diabetic-related chronic microvascular complications

    Time frame: From the last pregnancy to the study visit (≥3 years postpartum)

    Defined as diabetic retinopathy, chronic kidney disease or diabetic neuropathy

  7. Incident cardiovascular events

    Time frame: 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 outcomes

  1. Carotid intima-media thickness

    Time frame: At study visit (≥3 years postpartum)

    Measured by 2D ultrasonography

  2. Clinical diagnosis of preeclampsia in any pregnancy

    Time frame: At study visit (≥3 years postpartum)

    Preeclampsia diagnosis will follow the international criteria (Obstet Gynecol. 2020;135(6):e237-e260)

  3. Ambulatory glucose profile (continuous glucose monitoring)

    Time frame: 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)

  4. Cardiovascular Health Score

    Time frame: 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.

  5. Patient-reported outcomes. Hypoglycemia Fear Survey (HFS)

    Time frame: 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.

  6. Patient-reported outcomes. Clarke Score

    Time frame: 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.

  7. Patient-reported outcomes. Diabetes Quality of Life questionnaire (DQoL)

    Time frame: 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.

  8. Patient-reported outcomes. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  9. Patient-reported outcomes. Diabetes Distress Scale (DDS)

    Time frame: 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.

  10. Patient-reported outcomes. Problem Areas in Diabetes scale (PAID)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio J. Amor, MD, PhD

CONTACT

[email protected]

+34932279846

Verónica Perea, MD, PhD

CONTACT

[email protected]

+34 93 736 50 50

Sponsors and collaborators

Lead sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Other

Collaborators

  • Hospital Mutua de Terrassa
  • Sociedad Española de Endocrinología y Nutrición

Registry information

Acronym: PREEATH-T1D

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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