Type 1 DiabetesPREEATH-T1DNCT07479329
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
An observational study of Type 1 Diabetes and Preeclampsia, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Type 1 Diabetes, Preeclampsia, Preeclampsia (PE) Risk
- How many people
- 1,300 participants
- Where
- 2 sitesSpain
- Study dates
- 10 Apr 2026to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with type 1 diabetes followed in endocrinology clinics who had at least one previous pregnancy with documented first-trimester preeclampsia screening.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clínic Barcelona
Barcelona, Barcelona, 08036
- Not yet recruiting
Hospital Universitari Mútua Terrassa
Terrassa, Terrassa, 08221
About this study
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.
Read the 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).
- Conditions
- Type 1 Diabetes, Preeclampsia, Preeclampsia (PE) Risk
- Keywords
- Type 1 Diabetes, Preeclampsia, Preeclampsia Risk, Preclinical carotid atherosclerosis, Carotid ultrasonography, Cardiovascular risk, Cardiovascular disease
- Medical subject headings
- Diabetes Mellitus, Type 1, Pre-Eclampsia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of carotid plaques
Presence of focal carotid plaque defined as focal wall thickening ≥1.5 mm detected by standardized 2D carotid ultrasound.
Measured: At study visit (≥3 years postpartum)
Hemoglobin A1c (HbA1c)
HbA1c measured at study visit
Measured: 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.
Measured: At study visit (≥3 years postpartum)
Blood pressure
Systolic blood pressure and diastolic blood pressure.
Measured: At study visit (≥3 years postpartum)
Body mass index
Calculated as weight (in kg) / height (in meters) ^2
Measured: At study visit (≥3 years postpartum)
Diabetic-related chronic microvascular complications
Defined as diabetic retinopathy, chronic kidney disease or diabetic neuropathy
Measured: 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.
Measured: From last pregnancy to study visit (minimum 3 years)
Secondary outcomes (10)
Carotid intima-media thickness
Measured by 2D ultrasonography
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At study visit (≥3 years postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start10 Apr 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Sociedad Española de Endocrinología y Nutrición
- Responsible party
- Principal investigator, Antonio J. Amor, Institut d'Investigacions Biomèdiques August Pi i Sunyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479329
- Sponsor's protocol ID
- P/25-183
- Acronym
- PREEATH-T1D
- Status last verified
- Nov 2026
- First submitted
- 3 Mar 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40205402Perea 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.
PubMed 38149646Amor 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.
PubMed 34663538Amor 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.
PubMed 33238177Amor 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.
PubMed 32515046Amor 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.
PubMed 31529047
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07479329
- Acronym / sponsor ID
- PREEATH-T1D / P/25-183
- Conditions
- Type 1 Diabetes, Preeclampsia, Preeclampsia (PE) Risk
- Keywords
- Type 1 Diabetes, Preeclampsia, Preeclampsia Risk, Preclinical carotid atherosclerosis, Carotid ultrasonography, Cardiovascular risk, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i SunyerUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Sociedad Española de Endocrinología y Nutrición
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with type 1 diabetes followed in endocrinology clinics who had at least one previous pregnancy with documented first-trimester preeclampsia screening.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Hemoglobin A1c (HbA1c)
Time frame: At study visit (≥3 years postpartum)
HbA1c measured at study visit
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.
Blood pressure
Time frame: At study visit (≥3 years postpartum)
Systolic blood pressure and diastolic blood pressure.
Body mass index
Time frame: At study visit (≥3 years postpartum)
Calculated as weight (in kg) / height (in meters) ^2
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
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.
10 secondary outcomes
Carotid intima-media thickness
Time frame: At study visit (≥3 years postpartum)
Clinical diagnosis of preeclampsia in any pregnancy
Time frame: At study visit (≥3 years postpartum)
Ambulatory glucose profile (continuous glucose monitoring)
Time frame: Three months prior to study visit
Cardiovascular Health Score
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Hypoglycemia Fear Survey (HFS)
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Clarke Score
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Diabetes Quality of Life questionnaire (DQoL)
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Pittsburgh Sleep Quality Index (PSQI)
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Diabetes Distress Scale (DDS)
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Problem Areas in Diabetes scale (PAID)
Time frame: At study visit (≥3 years postpartum)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 40205402Mesa 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.
- Background: PubMed 38149646Perea 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.
- Background: PubMed 34663538Amor 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.
- Background: PubMed 33238177Amor 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.
- Background: PubMed 32515046Amor 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.
- Background: PubMed 31529047Amor 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Preeclampsia, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Verónica Perea, MD, PhD (+34 93 736 50 50, vperea@mutuaterrassa.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of carotid plaques (time frame: At study visit (≥3 years postpartum)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07479329, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.