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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03388788
Other study ID # IRB00017489
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date May 1, 2018
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Intervention

Radiation:
PET Imaging
Positron Emission Tomography (PET) imaging for research.
Behavioral:
Circadian Study Protocol
5-day circadian study schedule
Drug:
11C-Meta-Hydroxyephedrine (mHED)
11C-meta-hydroxyephedrine will be used during PET imaging to measure cardiac presynaptic norepinephrine transporter function.
11C-CGP12177
Cardiac beta adrenergic receptor density will be measured via PET imaging with infusion of 11C-CGP12177.
O15-water
Blood flow will be measured via PET imaging with infusion of O15-water.

Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

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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