Body Weight, Sleep, and Heart Health | NCT03388788

ID	Type	Description	Link
R01HL140577	U.S. NIH Grant/Contract		View source
KL2TR002370	U.S. NIH Grant/Contract		View source

Body Weight, Sleep, and Heart Health | NCT03388788 | Trialant

Sponsor/Collaborators Module

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH
National Center for Advancing Translational Sciences (NCATS)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal Weight		Healthy lean controls [18.5](streamdown:incomplete-link)	Combination Product: Positron Emission Tomography (PET) scanning of cardiac function at 3 time points across the 24 hour circadian cycle
Overweight		Healthy obese [30≤BMI<40 and waist circumference ≥94/80 (men and women respectively)] Healthy lean controls [18.5](streamdown:incomplete-link)	Combination Product: Positron Emission Tomography (PET) scanning of cardiac function at 3 time points across the 24 hour circadian cycle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Positron Emission Tomography (PET) scanning of cardiac function at 3 time points across the 24 hour circadian cycle	Combination Product	Drugs are used for as part of physiological monitoring and not as interventions, including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Pressure (BP)	Measurements were collected up to 7 times per participant across the circadian cycle under constant conditions across 5 days. Resting BP and Exercise BP data were collected at the beginning of each of 7 wake periods in a supine position and where participants exercised at an intensity equivalent to brisk walking. Salivary melatonin was used to calculate the circadian phase marker using dim light melatonin onset (DLMO). All data were assigned a circadian phase relative to DLMO and binned into 4-hour (or 60-degree) intervals. In the statistical analysis, the weight group refers to normal or overweight, exercise condition refers to seated or exercising on the bike, and circadian phase refers to the center of the circadian bin. This is an observational study. Due to insufficient enrollment and an imbalanced group distribution, we do not have sufficient statistical power to fully interpret these data. The data are valuable as pilot data for future investigations and sample size estimation.	5 Days

Secondary Outcomes

Measure	Description	Time Frame
Coronary Microvascular Blood Flux	Coronary microvascular function, measured as coronary microvascular blood flux using myocardial contrast echocardiography.	3 days
Flow Mediated Dilation (FMD)

Other Outcomes

Measure	Description	Time Frame
Beta-adrenergic Receptor Density (Exploratory Outcome)	Radiolabeled agonist (11C-CGP12177) to measure beta-adrenergic receptors during PET Imaging.	5 days.
Norepinephrine Reuptake Transport (Exploratory Outcome)

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Steven A Shea, PhD	Oregon Institute of Occupational Health Sciences	Principal Investigator
Jeanne M Link, PhD	OHSU Center for Radiochemistry Research	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health & Science University		Portland	Oregon	97239	United States

Arm/Group Information

ID	Title	Description
FG000	Normal Weight	Healthy lean controls [18.5](streamdown:incomplete-link)
FG001	Overweight	Healthy obese [30≤BMI<40 and waist circumference ≥94/80 (men and women respectively)] Healthy lean controls [18.5](streamdown:incomplete-link)

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00012 subjects FG0015 subjects
COMPLETED		FG00011 subjects FG0015 subjects
NOT COMPLETED		FG0001 subjects FG0010 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects FG0010 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	Normal Weight	Healthy lean controls [18.5](streamdown:incomplete-link)

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous	Age at screening

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Blood Pressure (BP)

Measurements were collected up to 7 times per participant across the circadian cycle under constant conditions across 5 days. Resting BP and Exercise BP data were collected at the beginning of each of 7 wake periods in a supine position and where participants exercised at an intensity equivalent to brisk walking. Salivary melatonin was used to calculate the circadian phase marker using dim light melatonin onset (DLMO). All data were assigned a circadian phase relative to DLMO and binned into 4-hour (or 60-degree) intervals. In the statistical analysis, the weight group refers to normal or overweight, exercise condition refers to seated or exercising on the bike, and circadian phase refers to the center of the circadian bin. This is an observational study. Due to insufficient enrollment and an imbalanced group distribution, we do not have sufficient statistical power to fully interpret these data. The data are valuable as pilot data for future investigations and sample size estimation.

These data were collected from an oscillometric blood pressure device.

Posted

Mean

Standard Error

mmHg

5 Days

ID	Title

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Normal Weight	Healthy lean controls [18.5](streamdown:incomplete-link)

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Intravenous (IV) Discomfort	Surgical and medical procedures	Standard terminology	Systematic Assessment	A subset of participants reported discomfort at the intravenous (IV) site, which necessitated catheter replacement. In addition, localized application of a heat pack was employed to mitigate the discomfort in individual cases, as appropriate.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Steven A Shea	Oregon Institute of Occupational Health Sciences, OHSU	5034942517		sheast@ohsu.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 5, 2025	Dec 8, 2025	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D021081	Chronobiology Disorders
D009765	Obesity

ID	Term
D009422	Nervous System Diseases
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Intervention Browse Module

ID	Term
D009682	Magnetic Resonance Spectroscopy
C062942	2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Race (NIH/OMB)

Race recorded at screening

There were 16 participants and the totals match.

Count of Participants

Participants

Title

Denominators

Categories

Supine Resting Systolic BP across the circadian cycle (see details below for statistical test)

Title	Measurements
	OG000111.27± 2.91 OG001113.99± 4.47

Supine Resting Diastolic BP across the circadian cycle (see details below for statistical test)

Title	Measurements
	OG00060.05± 1.96 OG00159.96± 3.00

Seated Resting Systolic BP across the circadian cycle (see below for statistical tests)

Title	Measurements
	OG000107.95± 3.78 OG001111.63± 5.90

Seated Exercise Systolic BP across the circadian cycle (see below for statistical tests)

Title	Measurements
	OG000140.95± 3.78 OG001148.42± 5.81

Seated Resting Diastolic BP across the circadian cycle (see below for statistical tests)

Title	Measurements
	OG00068.28± 1.33 OG00171.86± 2.11

Seated Exercise Diastolic BP across the circadian cycle (see below for statistical tests)

Title	Measurements
	OG00061.31± 1.34 OG00172.61± 2.08

Group IDs	Group Description	Statistical Method	P-Value	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	To test if there were differences in the circadian rhythm of systolic blood pressure between normal weight and overweight groups, we analyzed whether there was a significant circadian phase (Circadian bin center) by weight group interaction for Systolic BP. We collected up to 7 data points per participant. We used a mixed model approach with circadian phase and group as fixed factors, and subject as a random variable.	Mixed Models Analysis	0.18	Other	This is an observational study. Due to insufficient enrollment and an imbalanced group distribution, we do not have sufficient statistical power to fully interpret these data. The data are valuable as pilot data for future investigations and sample size estimation.
OG000 OG001	To test if there were differences in the circadian rhythm of Diastolic blood pressure between body weight groups, we analyzed whether there was a significant circadian phase (Circadian bin center) by group interaction for Diastolic BP. We collected up to 7 data points per participant. We used a mixed model approach with circadian phase and group as fixed factors, and subject as a random variable.	Mixed Models Analysis	0.28	Other	This is an observational study. Due to insufficient enrollment and an unbalanced group distribution, we do not have sufficient statistical power to fully interpret these data. The data are valuable as pilot data for future investigations and sample size estimation.
OG000 OG001	To test if there were differences in the circadian rhythm of reactivity of systolic BP to exercise between normal weight and overweight groups, we analyzed whether there was a significant circadian phase by weight group by exercise condition interaction for Systolic BP. We collected up to 7 data points per participant at rest and during exercise. We used a mixed model approach with circadian phase, exercise condition and group as fixed factors, and subject as a random variable.	Mixed Models Analysis	0.33	Other	This is an observational study. Due to insufficient enrollment and an unbalanced group distribution, we do not have sufficient statistical power to fully interpret these data. The data are valuable as pilot data for future investigations and sample size estimation.
OG000 OG001	To test if there were differences in the circadian rhythm of reactivity of Diastolic BP to exercise between normal weight and overweight groups, we analyzed whether there was a significant circadian phase by weight group by exercise condition interaction for Diastolic BP. We collected up to 7 data points per participant at rest and during exercise. We used a mixed model approach with circadian phase, exercise condition and group as fixed factors, and subject as a random variable.	Mixed Models Analysis	0.63	Other	This is an observational study. Due to insufficient enrollment and an unbalanced group distribution, we do not have sufficient statistical power to fully interpret these data. The data are valuable as pilot data for future investigations and sample size estimation.

OG000	Normal Weight	Healthy lean controls [18.5](streamdown:incomplete-link)
OG001	Overweight	Healthy obese [30≤BMI<40 and waist circumference ≥94/80 (men and women respectively)] Healthy lean controls [18.5](streamdown:incomplete-link)