Brain Health in Midlife (ADORE BRAIN)

June 16, 2026 updated by: University of Kansas Medical Center

Brain Health in Midlife (ADORE BRAIN)

The purpose of this study is to learn if hypertensive disorders during pregnancy affects brain health in midlife.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women who previously participated in the ADORE, received a hypertensive disorder diagnosis or had a healthy pregnancy during their participation.

Description

Inclusion Criteria:

  • Participated in the ADORE trial ( R01 HD083292)

Exclusion Criteria:

  • History of seizures or Epilepsy
  • Pregnant at screening
  • Ineligible to complete MRI due to metal in the body

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypertensive disorder of pregnancy
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
Diagnostic test: A combination of various tests and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy on brain health in midlife.
Participants will be asked to complete a blood draw, 5-lead ECG, MRI, a series of cognitive assessments, dietary assessments, monitor sleep and physical activity and DXA scan.
Healthy pregnancy
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
Diagnostic test: A combination of various tests and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy on brain health in midlife.
Participants will be asked to complete a blood draw, 5-lead ECG, MRI, a series of cognitive assessments, dietary assessments, monitor sleep and physical activity and DXA scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiometabolic Biomarkers - Glucose & Lipids
Time Frame: Baseline
Assess differences in cardiometabolic biomarkers between the women diagnosed with a hypertensive disorder of pregnancy and healthy control.
Baseline
Cardiometabolic Biomarkers - Insulin
Time Frame: Baseline
Assess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.
Baseline
Cardiometabolic Biomarkers - Hemoglobin A1C
Time Frame: Baseline
Assess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.
Baseline
Neurovascular Hemodynamics - Heart Rate
Time Frame: Baseline
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Heart rate was measured using a 5-lead electrocardiogram.
Baseline
Neurovascular Hemodynamics - Mean Arterial Pressure
Time Frame: Baseline
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Mean arterial pressure was measured with each heart beat using a specialized cuff placed on the finger.
Baseline
Neurovascular Hemodynamics - Cerebral Blood Flow
Time Frame: Baseline
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Cerebral blood flow, the velocity at which blood travels through the middle cerebral artery, was measured using transcranial doppler ultrasound.
Baseline
Neurovascular Hemodynamics - Pulse Wave Velocity
Time Frame: Baseline
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Pulse wave velocity is an indicator of vessel stiffness and was measured using a specialized blood pressure cuff placed on the upper thigh.
Baseline
Brain Structure
Time Frame: Baseline
Assess differences in brain structure between women diagnosed with a hypertensive disorder of pregnancy and healthy controls using fMRI. A T1-weighted structural scan was completed (3D MPRAGE sequence). Structural data was segmented using FreeSurfer to quantify brain volumes. Volumes are reported in cubic millimeters (mm^3).
Baseline
Brain Functional Connectivity
Time Frame: Baseline
Assess differences in brain functional connectivity between women diagnosed with a hypertensive disorder of pregnancy and healthy controls using fMRI. A resting state scan run of gradient echo blood oxygen level dependent (BOLD) scans was completed. Resting state data was processed using analysis protocols that explored functional neural networks (i.e., default mode network (DMN), attention network, salience network). Functional connectivity is reported as Fisher z-transformed correlation coefficients derived from fMRI data.
Baseline
Alzheimer's Disease-related Biomarkers
Time Frame: Baseline
Assess differences in Alzheimer's disease-related biomarkers between the women diagnosed with a hypertensive disorder of pregnancy and healthy control.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Holly R Hull, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Actual)

June 13, 2025

Study Completion (Actual)

June 13, 2025

Study Registration Dates

First Submitted

August 29, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00160885
  • P30AG072973 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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