NCT03388788

Body Weight, Sleep, and Heart Health

Circadian Mechanisms of Cardiovascular Risk in Obesity

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Cardiovascular Risk Factor
• Circadian Dysregulation
• Obesity

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-05-01
• Primary completion: 2024-09-30
• Completion: 2026-06-30
• First posted: 2018-01-03
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study