Clinical trial NCT03388788: Body Weight, Sleep, and Heart Health
Official title: Circadian Mechanisms of Cardiovascular Risk in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cardiovascular Risk Factor
Circadian Dysregulation
Obesity
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A multidisciplinary investigation examining the circadian mechanisms regulating cardiovascular (CV) risk in 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 in obesity. Furthermore, using an ingenious 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 CV rhythms predispose obese individuals to increased CV disease risk - particularly around the vulnerable morning period. The results will serve as a foundation for clinical trials of appropriately timed dosing of medications targeting aspects of the CV system in obesity that increase effectiveness while decreasing side-effects.

Eligibility 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)

Primary outcomes:
measure: Blood Pressure
timeFrame: 5 Days
Secondary outcomes:
measure: Heart Rate
timeFrame: 5 Days
measure: Epinephrine
timeFrame: 5 days
measure: Norepinephrine
timeFrame: 5 days
measure: Cortisol
timeFrame: 5 days
measure: Aldosterone
timeFrame: 5 days
measure: Endocannabinoid
timeFrame: 5 days
measure: Heart Rate Variability (HRV)
timeFrame: 5 days
measure: malondialdehyde (MDA) adducts
timeFrame: 5 days
measure: Flow Mediated Dilation (FMD)
timeFrame: 5 days
measure: Tumor Necrosis Factor alpha (TNF-alpha)
timeFrame: 5 days
measure: Coronary blood flow
timeFrame: 5 days.
measure: Norepinephrine reuptake transport
timeFrame: 5 days.
measure: Beta-adrenergic receptor density
timeFrame: 5 days.
measure: Dual Emission X-ray Absorbance (DEXA) Body composition
timeFrame: 1 day
measure: Coronary Artery Calcium Score
timeFrame: 1 scan.
measure: Coronary Microvascular Blood Flux
timeFrame: 3 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Institute of Occupational Health Sciences
name: Steven A Shea, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: OHSU Center for Radiochemistry Research
name: Jeanne M Link, PhD
role: PRINCIPAL_INVESTIGATOR
References: