Trial Outcomes & Findings for Body Weight, Sleep, and Heart Health (NCT NCT03388788)

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Target enrollment

17 participants

Primary outcome timeframe

5 Days

Results posted on

2026-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Normal Weight 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).	Overweight 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).
Overall Study STARTED	12	5
Overall Study COMPLETED	11	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Normal Weight 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).	Overweight 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).
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

There were 16 participants and the totals match.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Weight n=11 Participants 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).	Overweight n=5 Participants 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).	Total n=16 Participants Total of all reporting groups
Age, Continuous	40.21 Years STANDARD_DEVIATION 14.20 • n=11 Participants	42.88 Years STANDARD_DEVIATION 11.49 • n=9 Participants	41.05 Years STANDARD_DEVIATION 13.09 • n=20 Participants
Sex: Female, Male Female	6 Participants n=11 Participants	5 Participants n=9 Participants	11 Participants n=20 Participants
Sex: Female, Male Male	5 Participants n=11 Participants	0 Participants n=9 Participants	5 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants • There were 16 participants and the totals match.	0 Participants n=9 Participants • There were 16 participants and the totals match.	0 Participants n=20 Participants • There were 16 participants and the totals match.
Race (NIH/OMB) Asian	1 Participants n=11 Participants • There were 16 participants and the totals match.	0 Participants n=9 Participants • There were 16 participants and the totals match.	1 Participants n=20 Participants • There were 16 participants and the totals match.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants • There were 16 participants and the totals match.	0 Participants n=9 Participants • There were 16 participants and the totals match.	0 Participants n=20 Participants • There were 16 participants and the totals match.
Race (NIH/OMB) Black or African American	0 Participants n=11 Participants • There were 16 participants and the totals match.	0 Participants n=9 Participants • There were 16 participants and the totals match.	0 Participants n=20 Participants • There were 16 participants and the totals match.
Race (NIH/OMB) White	10 Participants n=11 Participants • There were 16 participants and the totals match.	5 Participants n=9 Participants • There were 16 participants and the totals match.	15 Participants n=20 Participants • There were 16 participants and the totals match.
Race (NIH/OMB) More than one race	0 Participants n=11 Participants • There were 16 participants and the totals match.	0 Participants n=9 Participants • There were 16 participants and the totals match.	0 Participants n=20 Participants • There were 16 participants and the totals match.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants • There were 16 participants and the totals match.	0 Participants n=9 Participants • There were 16 participants and the totals match.	0 Participants n=20 Participants • There were 16 participants and the totals match.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=11 Participants • There were 16 participants, all of them identified as Not Hispanic or Latino	0 Participants n=9 Participants • There were 16 participants, all of them identified as Not Hispanic or Latino	0 Participants n=20 Participants • There were 16 participants, all of them identified as Not Hispanic or Latino
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=11 Participants • There were 16 participants, all of them identified as Not Hispanic or Latino	5 Participants n=9 Participants • There were 16 participants, all of them identified as Not Hispanic or Latino	16 Participants n=20 Participants • There were 16 participants, all of them identified as Not Hispanic or Latino
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants • There were 16 participants, all of them identified as Not Hispanic or Latino	0 Participants n=9 Participants • There were 16 participants, all of them identified as Not Hispanic or Latino	0 Participants n=20 Participants • There were 16 participants, all of them identified as Not Hispanic or Latino
BMI	21.94 kg/meter squared STANDARD_DEVIATION 1.86 • n=11 Participants	34.04 kg/meter squared STANDARD_DEVIATION 2.40 • n=9 Participants	25.73 kg/meter squared STANDARD_DEVIATION 6.11 • n=20 Participants

PRIMARY outcome

Timeframe: 5 Days

Population: These data were collected from an oscillometric blood pressure device.

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.

Outcome measures

Outcome measures
Measure	Normal Weight n=11 Participants 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). 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).	Overweight n=5 Participants 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). 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).
Blood Pressure (BP) Seated Resting Systolic BP across the circadian cycle (see below for statistical tests)	107.95 mmHg Standard Error 3.78	111.63 mmHg Standard Error 5.90
Blood Pressure (BP) Seated Exercise Systolic BP across the circadian cycle (see below for statistical tests)	140.95 mmHg Standard Error 3.78	148.42 mmHg Standard Error 5.81
Blood Pressure (BP) Seated Resting Diastolic BP across the circadian cycle (see below for statistical tests)	68.28 mmHg Standard Error 1.33	71.86 mmHg Standard Error 2.11
Blood Pressure (BP) Seated Exercise Diastolic BP across the circadian cycle (see below for statistical tests)	61.31 mmHg Standard Error 1.34	72.61 mmHg Standard Error 2.08
Blood Pressure (BP) Supine Resting Systolic BP across the circadian cycle (see details below for statistical test)	111.27 mmHg Standard Error 2.91	113.99 mmHg Standard Error 4.47
Blood Pressure (BP) Supine Resting Diastolic BP across the circadian cycle (see details below for statistical test)	60.05 mmHg Standard Error 1.96	59.96 mmHg Standard Error 3.00

Adverse Events

Normal Weight

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Overweight

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Normal Weight n=12 participants at risk 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).	Overweight n=5 participants at risk 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).
Surgical and medical procedures Intravenous (IV) Discomfort	16.7% 2/12 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.	40.0% 2/5 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
Surgical and medical procedures Regadenoson Infusion Symptoms	33.3% 4/12 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.	20.0% 1/5 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
Surgical and medical procedures PET Scan Position Discomfort	8.3% 1/12 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.	20.0% 1/5 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
General disorders General Discomforts	16.7% 2/12 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.	0.00% 0/5 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
Eye disorders Eye Discomfort	8.3% 1/12 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.	0.00% 0/5 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
Social circumstances Emotional Discomfort	8.3% 1/12 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.	20.0% 1/5 • From enrollment until end of follow-up (1 week after the in-laboratory monitoring) Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological well-being), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.

Additional Information

Steven A Shea

Oregon Institute of Occupational Health Sciences, OHSU

Phone: 5034942517

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place