Clinical trial

Body Weight, Sleep, and Heart Health

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT03388788

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionCardiovascular Risk Factor, Circadian Dysregulation, Obesity

Full registry criteria

Inclusion Criteria: * Ages 25-65 * Lean and overweight (BMI 18.5-40kg/m2) * Habitually sedentary Exclusion Criteria: * History of smoking/tobacco use * Insomnia * Moderate to severe obstructive sleep apnea. * Prior shift work within 6 months prior to the study. * Prescription medications * Drugs of abuse * Acute, chronic, or debilitating medical condition (including diabetes, hypertension, and metabolic syndrome)

Treatments and study arms

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).

Primary outcomes

Blood Pressure (BP)5 Days

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 t…

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Oregon Health & Science University🇺🇸 Portland, Oregon, United States

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