Body Weight, Sleep, and Heart Health

Obesity Clinical Trial

Official title:

Circadian Mechanisms of Cardiovascular Risk in Obesity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03388788
• Other study ID #: IRB00017489
• Status: Active, not recruiting
• Phase: Early Phase 1
• 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
• 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)

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Chronobiology Disorders
• Circadian Dysregulation
• Obesity

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