Body Weight, Sleep, and Heart Health

Oregon Health & Science University (OHSU)

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Obesity; Circadian Dysregulation; Cardiovascular Risk Factor

Treatments: Combination Product: Positron Emission Tomography (PET) scanning of cardiac function at 3 time points across the 24 hour circadian cycle

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03388788

IRB00017489

KL2TR002370 (U.S. NIH Grant/Contract)

R01HL140577 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

16 participants in 2 patient groups

Normal Weight

Description:

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).

Treatment:

Combination Product: Positron Emission Tomography (PET) scanning of cardiac function at 3 time points across the 24 hour circadian cycle

Overweight

Description:

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).

Treatment:

Combination Product: Positron Emission Tomography (PET) scanning of cardiac function at 3 time points across the 24 hour circadian cycle