Obesity's Impact on Heart Health

Overseen By Andrew McHill

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Oregon Health and Science University

Must not be taking: Prescription medications, Drugs of abuse

Disqualifiers: Smoking, Insomnia, Sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jeanne M Link, PhD

Principal Investigator

OHSU Center for Radiochemistry Research

Steven A Shea, PhD

Principal Investigator

Oregon Institute of Occupational Health Sciences

Eligibility Criteria

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.

Inclusion Criteria

I am between 25 and 65 years old.

My BMI is between 18.5 and 40.

Habitually sedentary

Exclusion Criteria

History of smoking/tobacco use

I have trouble sleeping.

Drugs of abuse

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Circadian Study Protocol

Participants undergo a 5-day circadian study protocol with PET imaging using radiopharmaceuticals

5 days

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the study protocol

4 weeks

Treatment Details

Interventions

• 11C-CGP12177
• 11C-Meta-Hydroxyephedrine (mHED)
• Circadian Study Protocol
• O15-water

Trial Overview 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.

Participant Groups

Group I: Overweight Experimental Treatment 5 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 Weight Experimental Treatment 5 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).

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+