Trial Outcomes & Findings for Brain Health in Midlife (NCT NCT06640842)
NCT ID: NCT06640842
Last Updated: 2026-07-14
Results Overview
Assess differences in cardiometabolic biomarkers between the women diagnosed with a hypertensive disorder of pregnancy and healthy control.
COMPLETED
24 participants
Baseline
2026-07-14
Participant Flow
Participant milestones
| Measure |
Hypertensive Disorder of Pregnancy
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Health in Midlife
Baseline characteristics by cohort
| Measure |
Hypertensive Disorder of Pregnancy
n=12 Participants
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
n=12 Participants
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 3.74 • n=9 Participants
|
41.6 years
STANDARD_DEVIATION 3.32 • n=27 Participants
|
41.8 years
STANDARD_DEVIATION 3.46 • n=267 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
BMI
|
29.550 kg/m^2
STANDARD_DEVIATION 6.7084 • n=9 Participants
|
28.908 kg/m^2
STANDARD_DEVIATION 4.6859 • n=27 Participants
|
29.229 kg/m^2
STANDARD_DEVIATION 5.6685 • n=267 Participants
|
PRIMARY outcome
Timeframe: BaselineAssess differences in cardiometabolic biomarkers between the women diagnosed with a hypertensive disorder of pregnancy and healthy control.
Outcome measures
| Measure |
Hypertensive Disorder of Pregnancy
n=12 Participants
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
n=12 Participants
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
|---|---|---|
|
Cardiometabolic Biomarkers - Glucose & Lipids
Fasting Glucose (mg/dL)
|
93.25 mg/dL
Standard Deviation 15.71
|
94.50 mg/dL
Standard Deviation 13.53
|
|
Cardiometabolic Biomarkers - Glucose & Lipids
Total Cholesterol (mg/dL)
|
170 mg/dL
Standard Deviation 38.69
|
172.50 mg/dL
Standard Deviation 28.27
|
|
Cardiometabolic Biomarkers - Glucose & Lipids
Triglycerides (mg/dL)
|
92.58 mg/dL
Standard Deviation 32.81
|
132.42 mg/dL
Standard Deviation 83.07
|
|
Cardiometabolic Biomarkers - Glucose & Lipids
High-Density Lipoprotein (HDL) (mg/dL)
|
55.42 mg/dL
Standard Deviation 11.49
|
46.92 mg/dL
Standard Deviation 11.68
|
|
Cardiometabolic Biomarkers - Glucose & Lipids
Low-Density Lipoprotein (LDL) (mg/dL)
|
107.58 mg/dL
Standard Deviation 35.20
|
113.17 mg/dL
Standard Deviation 17.24
|
PRIMARY outcome
Timeframe: BaselineAssess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.
Outcome measures
| Measure |
Hypertensive Disorder of Pregnancy
n=12 Participants
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
n=12 Participants
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
|---|---|---|
|
Cardiometabolic Biomarkers - Insulin
|
7.44 uIU/mL
Standard Deviation 3.63
|
14.13 uIU/mL
Standard Deviation 12.97
|
PRIMARY outcome
Timeframe: BaselineAssess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.
Outcome measures
| Measure |
Hypertensive Disorder of Pregnancy
n=12 Participants
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
n=12 Participants
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
|---|---|---|
|
Cardiometabolic Biomarkers - Hemoglobin A1C
|
5.72 percentage of glycated hemoglobin
Standard Deviation 1.09
|
5.45 percentage of glycated hemoglobin
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: BaselinePopulation: Due to reasons beyond the study's team control (i.e. medical condition(s), technology and/or time) Cerebral blood flow and Pulse wave velocity was not acquired for all participants.
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.
Outcome measures
| Measure |
Hypertensive Disorder of Pregnancy
n=12 Participants
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
n=12 Participants
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
|---|---|---|
|
Neurovascular Hemodynamics - Heart Rate
|
75.53 beats/min
Standard Deviation 6.71
|
65.16 beats/min
Standard Deviation 6.35
|
PRIMARY outcome
Timeframe: BaselinePopulation: Due to reasons beyond the study's team control (i.e. medical condition(s), technology and/or time) Cerebral blood flow and Pulse wave velocity was not acquired for all participants.
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.
Outcome measures
| Measure |
Hypertensive Disorder of Pregnancy
n=12 Participants
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
n=12 Participants
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
|---|---|---|
|
Neurovascular Hemodynamics - Mean Arterial Pressure
|
83.61 mmHg
Standard Deviation 14.52
|
75.84 mmHg
Standard Deviation 5.43
|
PRIMARY outcome
Timeframe: BaselinePopulation: Due to reasons beyond the study's team control (i.e. medical condition(s), technology and/or time) Cerebral blood flow and Pulse wave velocity was not acquired for all participants.
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.
Outcome measures
| Measure |
Hypertensive Disorder of Pregnancy
n=11 Participants
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
n=11 Participants
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
|---|---|---|
|
Neurovascular Hemodynamics - Cerebral Blood Flow
|
73.65 cm/sec
Standard Deviation 10.08
|
75.69 cm/sec
Standard Deviation 12.49
|
PRIMARY outcome
Timeframe: BaselinePopulation: Due to reasons beyond the study's team control (i.e. medical condition(s), technology and/or time) Cerebral blood flow and Pulse wave velocity was not acquired for all participants.
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.
Outcome measures
| Measure |
Hypertensive Disorder of Pregnancy
n=8 Participants
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
n=9 Participants
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
|---|---|---|
|
Neurovascular Hemodynamics - Pulse Wave Velocity
|
6.99 meters/sec
Standard Deviation 0.48
|
-4.98 meters/sec
Standard Deviation 35.27
|
PRIMARY outcome
Timeframe: BaselinePopulation: 19 participants had usable segmentation data for brain structure; 3 were excluded because segmentation failed due to image quality.
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).
Outcome measures
| Measure |
Hypertensive Disorder of Pregnancy
n=8 Participants
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
n=11 Participants
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
|---|---|---|
|
Brain Structure
Total Cortical Gray Matter Volume
|
0.41 mm^3
Standard Deviation 0.11
|
0.41 mm^3
Standard Deviation 0.12
|
|
Brain Structure
Total Cerebral White Matter Volume
|
0.45 mm^3
Standard Deviation 0.16
|
0.44 mm^3
Standard Deviation 0.14
|
|
Brain Structure
Left Hippocampal Brain Volume
|
0.004 mm^3
Standard Deviation 0.001
|
0.003 mm^3
Standard Deviation 0.001
|
|
Brain Structure
Right Hippocampal Brain Volume
|
0.004 mm^3
Standard Deviation 0.001
|
0.003 mm^3
Standard Deviation 0.001
|
PRIMARY outcome
Timeframe: BaselinePopulation: For resting state scan: 16 participants had usable data; the remaining 6 either had significant motion, did not complete scan, or data was excluded due to image distortion.
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.
Outcome measures
| Measure |
Hypertensive Disorder of Pregnancy
n=7 Participants
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
n=9 Participants
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
|---|---|---|
|
Brain Functional Connectivity
Connectivity between DMN and left ventral attention network
|
-0.02 Fisher z-score
Standard Deviation 0.14
|
0.13 Fisher z-score
Standard Deviation 0.19
|
|
Brain Functional Connectivity
Connectivity between DMN and right ventral attention network
|
0.19 Fisher z-score
Standard Deviation 0.10
|
0.14 Fisher z-score
Standard Deviation 0.22
|
|
Brain Functional Connectivity
Connectivity between DMN and left dorsal attention network
|
-0.02 Fisher z-score
Standard Deviation 0.14
|
0.10 Fisher z-score
Standard Deviation 0.19
|
|
Brain Functional Connectivity
Connectivity between DMN and right dorsal attention network
|
-0.06 Fisher z-score
Standard Deviation 0.14
|
0.04 Fisher z-score
Standard Deviation 0.20
|
|
Brain Functional Connectivity
Within default mode network (DMN) connectivity
|
0.74 Fisher z-score
Standard Deviation 0.23
|
0.56 Fisher z-score
Standard Deviation 0.28
|
|
Brain Functional Connectivity
Within salience network connectivity
|
0.46 Fisher z-score
Standard Deviation 0.10
|
0.47 Fisher z-score
Standard Deviation 0.20
|
|
Brain Functional Connectivity
Within ventral attention network connectivity
|
0.47 Fisher z-score
Standard Deviation 0.20
|
0.43 Fisher z-score
Standard Deviation 0.13
|
|
Brain Functional Connectivity
Within dorsal attention network connectivity
|
0.62 Fisher z-score
Standard Deviation 0.22
|
0.64 Fisher z-score
Standard Deviation 0.25
|
|
Brain Functional Connectivity
Connectivity between DMV and salience dorsal anterior cingulate cortex
|
0.09 Fisher z-score
Standard Deviation 0.10
|
0.02 Fisher z-score
Standard Deviation 0.31
|
|
Brain Functional Connectivity
Connectivity between DMV and salience right anterior insula
|
0.01 Fisher z-score
Standard Deviation 0.21
|
-0.03 Fisher z-score
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: BaselineAssess differences in Alzheimer's disease-related biomarkers between the women diagnosed with a hypertensive disorder of pregnancy and healthy control.
Outcome measures
| Measure |
Hypertensive Disorder of Pregnancy
n=12 Participants
Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.
|
Healthy Pregnancy
n=12 Participants
Women who participated in the ADORE study and had a healthy pregnancy during their participation.
|
|---|---|---|
|
Alzheimer's Disease-related Biomarkers
Neurofilament Light Chain (NfL)
|
10.27 pg/mL
Standard Deviation 4.60
|
7.97 pg/mL
Standard Deviation 2.91
|
|
Alzheimer's Disease-related Biomarkers
Glial Fibrillary Acidic Protein (GFAP)
|
67.81 pg/mL
Standard Deviation 18.33
|
61.06 pg/mL
Standard Deviation 23.72
|
|
Alzheimer's Disease-related Biomarkers
pTau217
|
0.16 pg/mL
Standard Deviation 0.06
|
0.14 pg/mL
Standard Deviation 0.04
|
|
Alzheimer's Disease-related Biomarkers
Interleukin-1 beta (IL-1β)
|
0.02 pg/mL
Standard Deviation 0.01
|
0.02 pg/mL
Standard Deviation 0.01
|
|
Alzheimer's Disease-related Biomarkers
Interleukin-6
|
10.90 pg/mL
Standard Deviation 23.94
|
4.20 pg/mL
Standard Deviation 5.59
|
|
Alzheimer's Disease-related Biomarkers
Interleukin-10
|
3.20 pg/mL
Standard Deviation 0.91
|
4.45 pg/mL
Standard Deviation 2.19
|
|
Alzheimer's Disease-related Biomarkers
Tumor Necrosis Factor alpha (TNF-α)
|
4.52 pg/mL
Standard Deviation 0.97
|
5.41 pg/mL
Standard Deviation 0.96
|
Adverse Events
Hypertensive Disorder of Pregnancy
Healthy Pregnancy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Holly Hull
The University of Kansas Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place