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Circadian Study Protocol for Cardiovascular Risk

Phase < 1
Waitlist Available
Led By Jeanne M Link, PhD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 25-65
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights

Study Summary

This trial is investigating how obesity affects the risk of cardiovascular problems, and how different stressors affect this risk. They will also study how well the heart functions in people with obesity.

Who is the study for?
This trial is for adults aged 25-65 who are not very active and have a body mass index (BMI) between 18.5 to 40, meaning they range from normal weight to obese. It's not open to smokers, those with sleep issues like insomnia or severe sleep apnea, anyone on prescription meds or using drugs of abuse, or people with certain medical conditions including diabetes and high blood pressure.Check my eligibility
What is being tested?
The study is looking at how the body's daily rhythms affect heart health in overweight individuals by measuring cardiovascular risk markers at rest and in response to stress. Participants will undergo PET imaging using specific tracers like 11C-CGP12177 and mHED as well as O15-water to assess heart function.See study design
What are the potential side effects?
Potential side effects may include discomfort from the imaging process such as feeling claustrophobic inside the PET scanner. The tracers used could cause allergic reactions or other mild symptoms but are generally considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 25 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Pressure
Secondary outcome measures
Aldosterone
Beta-adrenergic receptor
Coronary Artery Calcium Score
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: OverweightExperimental Treatment5 Interventions
Healthy obese [30≤BMI<40 and waist circumference (WC) ≥94/80 (men and women respectively)] will participate in a 5-day circadian study protocol with PET imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, 11C-CGP12177, and O15-water).
Group II: Normal WeightExperimental Treatment5 Interventions
Healthy lean controls [18.5<BMI<25 kg/m2 and WC <94/80 (men and women respectively)] will participate in a 5-day circadian study protocol with PET imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, 11C-CGP12177, and O15-water).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET Imaging
2008
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
979 Previous Clinical Trials
7,386,445 Total Patients Enrolled
6 Trials studying Cardiovascular Risk
1,666 Patients Enrolled for Cardiovascular Risk
Jeanne M Link, PhDPrincipal InvestigatorOHSU Center for Radiochemistry Research
Steven A Shea, PhDPrincipal InvestigatorOregon Institute of Occupational Health Sciences
3 Previous Clinical Trials
109 Total Patients Enrolled
1 Trials studying Cardiovascular Risk
52 Patients Enrolled for Cardiovascular Risk
~1 spots leftby Sep 2024
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