Obesity Clinical Trial
Official title:
Circadian Mechanisms of Cardiovascular Risk in Obesity
Verified date | May 2024 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 16 |
Est. completion date | December 31, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Pressure | Beat-by-beat and ambulatory blood pressure measurements. | 5 Days | |
Secondary | Heart Rate | Heart rate via 2-channel echocardiogram (ECG) | 5 Days | |
Secondary | Epinephrine | Venous Epinephrine to estimate sympathetic output | 5 days | |
Secondary | Norepinephrine | Venous Norepinephrine to estimate sympathetic output | 5 days | |
Secondary | Cortisol | Saliva cortisol to estimate sympathetic output | 5 days | |
Secondary | Aldosterone | Venous Aldosterone to estimate sympathetic output | 5 days | |
Secondary | Endocannabinoid | Plasma endocannabinoid to estimate sympathetic regulation | 5 days | |
Secondary | Heart Rate Variability (HRV) | Analysis of HRV from 12-lead ECG to assess parasympathetic activity | 5 days | |
Secondary | malondialdehyde (MDA) adducts | Plasma MDA to measure oxidative stress and inflammation. | 5 days | |
Secondary | Flow Mediated Dilation (FMD) | FMD to measure endothelial function. | 5 days | |
Secondary | Tumor Necrosis Factor alpha (TNF-alpha) | TNF-alpha to assess inflammation. | 5 days | |
Secondary | Coronary blood flow | Radiolabeled water (O15-water) to measure coronary blood flow during PET Imaging. | 5 days. | |
Secondary | Norepinephrine reuptake transport | Radiolabeled meta-hydroxyephedrine (11C-mHED) to measure norepinephrine reuptake during PET Imaging. | 5 days. | |
Secondary | Beta-adrenergic receptor density | Radiolabeled agonist (11C-CGP12177) to measure beta-adrenergic receptors during PET Imaging. | 5 days. | |
Secondary | Dual Emission X-ray Absorbance (DEXA) Body composition | DEXA imaging to assess body composition. | 1 day | |
Secondary | Coronary Artery Calcium Score | Coronary Calcium Computed Tomography (CT) Scan | 1 scan. | |
Secondary | Coronary Microvascular Blood Flux | 1. Determine in lean healthy humans if coronary microvascular function, measured as coronary microvascular blood flux, has an endogenous circadian rhythm with lowest function in the morning. 2. Test the hypothesis that people with obesity have impaired coronary microvascular blood flux compared to lean individuals, with the exaggerated impairment during the morning. Measured using myocardial contrast echocardiography. | 3 days |
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