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Obesity's Impact on Heart Health

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

Must not have

Acute, chronic, or debilitating medical condition (including diabetes, hypertension, and metabolic syndrome)

Moderate to severe obstructive sleep apnea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 days

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am between 25 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a long-term health condition like diabetes or high blood pressure.

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I have been diagnosed with moderate to severe sleep apnea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood Pressure

Secondary study objectives

Aldosterone

Beta-adrenergic receptor

Coronary Artery Calcium Score

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met