An observational study in Cardiovascular Risk Factor, Circadian Dysregulation and Obesity, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Oregon Health and Science University · Observational
Among 58 studies in Chronobiology Disorders with a site in United States — 8 open to participants now, 11 under way, none of them phase 3. Chronobiology Disorders · United States.
Among the 58 studies in Chronobiology Disorders with a site in United States, this one is the 9th largest by enrollment of the 12 observational ones, is one of 4 that started in 2018, is one of 12 observational ones, and was the 21st registered.
102 studies on the registry are indexed under Chronobiology Disorders; 22 are open to participants now.
This study's enrollment of 17 is below the median of 80 across 33 observational studies indexed under Chronobiology Disorders.
Browse Chronobiology Disorders studies →8 of the 58 studies in Chronobiology Disorders with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 18 Chronobiology Disorders studies recruiting now, 9 (50%) set no upper age limit and 8 (44%) stop at 75 or younger; 2 take children under 18; 8 take healthy volunteers.
This study: 25 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →58 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 4 started in 2018.
Median enrollment 71 across the 46 interventional studies, 40 across the 12 observational. Of the 46 that completed or were terminated, 18 (39%) have results posted.
9 of 58 have an industry lead sponsor. The 10 most frequent:
Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
Oregon Health and Science University has 1 study filed under Chronobiology Disorders — fewer than ten, so there is no comparison to draw.
4 of the studies in Chronobiology Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07459764Stanford UniversityBody Clocks - Coordination of Peripheral and Central Oscillators | 2026-11-10 |
| NCT07384585Laura Beth KalvasFeasibility of Light Therapy in the Pediatric Intensive Care Unit (ICU) | 2027-01 |
| NCT06430853Stanford UniversityPsychobiological Interventions in Pregnancy | 2027-01-01 |
| NCT04578249West Virginia UniversityEffects of Blocking Blue Light at Night Post CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH | 2027-05 |
Among the 58 studies in Chronobiology Disorders with a site in United States, from their registry updates:
A multidisciplinary investigation examining the circadian mechanisms regulating cardiovascular (CV) risk, with an additional focus on obesity. Specifically, in a valid circadian protocol, the investigators aim to study resting cardiovascular risk markers and the reactivity of circadian rhythms in these risk markers to standardized stressors. It is intended to compare results in lean and obese individuals to determine if there are specific risks across the circadian cycle specific to obesity. Furthermore, using an exploratory approach, the investigators propose to explore impairment in pre/post synaptic function in the cardiac left ventricle.
Overall, these studies will help us answer whether the circadian system predispose individuals to increased CV disease risk - particularly around the vulnerable morning period, and whether these risks differ with obesity. The results will serve as a foundation for clinical trials of appropriately timed dosing of medications targeting aspects of the CV system that increase effectiveness while decreasing side effects, and may have particular relevance to management of CV risk in people with obesity.
Community sample
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy lean controls \[18.5\<BMI\<25 kg/m2 and waist circumference \<94/80 cm (men/women respectively)\] will participate in a 5-day circadian study protocol with numerous repeated cardiovascular measures across the circadian cycle. Drugs are used as part of physiological monitoring and not as interventions including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).
Combination Product: Positron Emission Tomography (PET) scanning of cardiac function at 3 time points across the 24 hour circadian cycle
Healthy obese \[30≤BMI\<40 and waist circumference ≥94/80 (men and women respectively)\] Healthy lean controls \[18.5\<BMI\<25 kg/m2 and waist circumference \<94/80 cm (men/women respectively)\] will participate in a 5-day circadian study protocol with numerous repeated cardiovascular measures across the circadian cycle. Drugs are used as part of physiological monitoring and not as interventions including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).
Combination Product: Positron Emission Tomography (PET) scanning of cardiac function at 3 time points across the 24 hour circadian cycle
Drugs are used for as part of physiological monitoring and not as interventions, including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).
Also known as: PET scanning
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.
Time frame: 5 Days
Coronary Microvascular Blood Flux
Coronary microvascular function, measured as coronary microvascular blood flux using myocardial contrast echocardiography.
Time frame: 3 days
Flow Mediated Dilation (FMD)
FMD to measure endothelial function.
Time frame: 5 days
Heart Rate
Heart rate via 2-channel echocardiogram (ECG)
Time frame: 5 Days
Epinephrine
Venous Epinephrine to estimate sympathetic output
Time frame: 5 days
Norepinephrine
Venous Norepinephrine to estimate sympathetic output
Time frame: 5 days
Cortisol
Saliva cortisol to estimate sympathetic output
Time frame: 5 days
Beta-adrenergic Receptor Density (Exploratory Outcome)
Radiolabeled agonist (11C-CGP12177) to measure beta-adrenergic receptors during PET Imaging.
Time frame: 5 days.
Norepinephrine Reuptake Transport (Exploratory Outcome)
Radiolabeled meta-hydroxyephedrine (11C-mHED) to measure norepinephrine reuptake during PET Imaging.
Time frame: 5 days.
| Milestone | Normal Weight | Overweight |
|---|---|---|
| Started | 12 | 5 |
| Completed | 11 | 5 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| mmHg | Normal Weight | Overweight |
|---|---|---|
| Supine Resting Systolic BP across the circadian cycle (see details below for statistical test) | 111.27 ± 2.91 | 113.99 ± 4.47 |
| Supine Resting Diastolic BP across the circadian cycle (see details below for statistical test) | 60.05 ± 1.96 | 59.96 ± 3.00 |
| Seated Resting Systolic BP across the circadian cycle (see below for statistical tests) | 107.95 ± 3.78 | 111.63 ± 5.90 |
| Seated Exercise Systolic BP across the circadian cycle (see below for statistical tests) | 140.95 ± 3.78 | 148.42 ± 5.81 |
| Seated Resting Diastolic BP across the circadian cycle (see below for statistical tests) | 68.28 ± 1.33 | 71.86 ± 2.11 |
| Seated Exercise Diastolic BP across the circadian cycle (see below for statistical tests) | 61.31 ± 1.34 | 72.61 ± 2.08 |
Coronary microvascular function, measured as coronary microvascular blood flux using myocardial contrast echocardiography.
Results for this outcome have not been posted.
FMD to measure endothelial function.
Results for this outcome have not been posted.
Heart rate via 2-channel echocardiogram (ECG)
Results for this outcome have not been posted.
Venous Epinephrine to estimate sympathetic output
Results for this outcome have not been posted.
Venous Norepinephrine to estimate sympathetic output
Results for this outcome have not been posted.
Saliva cortisol to estimate sympathetic output
Results for this outcome have not been posted.
Radiolabeled agonist (11C-CGP12177) to measure beta-adrenergic receptors during PET Imaging.
Results for this outcome have not been posted.
Radiolabeled meta-hydroxyephedrine (11C-mHED) to measure norepinephrine reuptake during PET Imaging.
Results for this outcome have not been posted.
Collected over From enrollment until end of follow-up (1 week after the in-laboratory monitoring). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Normal Weight | 0/12 (0%) | 0/12 (0%) | 5/12 (41.7%) |
| Overweight | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| Event | Normal Weight | Overweight |
|---|---|---|
| Intravenous (IV) DiscomfortSurgical and medical procedures | 2/12 | 2/5 |
| Regadenoson Infusion SymptomsSurgical and medical procedures | 4/12 | 1/5 |
| PET Scan Position DiscomfortSurgical and medical procedures | 1/12 | 1/5 |
| Emotional DiscomfortSocial circumstances | 1/12 | 1/5 |
| General DiscomfortsGeneral disorders | 2/12 | 0/5 |
| Eye DiscomfortEye disorders | 1/12 | 0/5 |
| Age, Continuous(Years) | Normal Weight | Overweight | Total |
|---|---|---|---|
| Mean | 40.21 ± 14.20 | 42.88 ± 11.49 | 41.05 ± 13.09 |
| Sex: Female, Male(Participants) | Normal Weight | Overweight | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 5 | 0 | 5 |
| Race (NIH/OMB)(Participants) | Normal Weight | Overweight | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 10 | 5 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Normal Weight | Overweight | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 11 | 5 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 |
| BMI(kg/meter squared) | Normal Weight | Overweight | Total |
|---|---|---|---|
| Mean | 21.94 ± 1.86 | 34.04 ± 2.40 | 25.73 ± 6.11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Sep 2024, 76 months.
Results were first posted in May 2026, 1 year 7 months after primary completion.
Of 19 observational studies under Chronobiology Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's 76 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University →