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Clinical Trials/NCT03388788
NCT03388788
Active, not recruiting
Early Phase 1

Circadian Mechanisms of Cardiovascular Risk in Obesity

Oregon Health and Science University1 site in 1 country16 target enrollmentMay 1, 2018

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Cardiovascular Risk Factor
Sponsor
Oregon Health and Science University
Enrollment
16
Locations
1
Primary Endpoint
Blood Pressure
Status
Active, not recruiting
Last Updated
4 months ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
June 30, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven A. Shea

Director

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • Ages 25-65
  • Lean and overweight (BMI 18.5-40kg/m2)
  • Habitually sedentary

Exclusion Criteria

  • History of smoking/tobacco use
  • 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)

Outcomes

Primary Outcomes

Blood Pressure

Time Frame: 5 Days

Beat-by-beat and ambulatory blood pressure measurements.

Secondary Outcomes

  • Epinephrine(5 days)
  • Cortisol(5 days)
  • Coronary Microvascular Blood Flux(3 days)
  • Flow Mediated Dilation (FMD)(5 days)
  • Heart Rate(5 Days)
  • Norepinephrine(5 days)

Study Sites (1)

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