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Circadian Study Protocol for Cardiovascular Risk

Q: Who can be accepted into the cohort of this trial?

This clinical trial is aiming to involve 28 individuals aged between 25 and 65 who are struggling with <a href="https://www.withpower.com/clinical-trials/obesity">obesity</a>. Eligible participants must also fall within the BMI range of 18.5 - 40kg/m2, while being habitually sedentary.

Q: What is the upper limit on the number of participants for this investigation?

Yes, the clinical trial is still open for enrollment. The initial post was made on May 1st 2018 with a subsequent update occurring on February 3rd 2022. Presently, 28 volunteers are needed from one centre.

Q: Is recruitment for this test still taking place?

According to clinicaltrials.gov, this review is actively recruiting patients with the initial posting appearing on May 1st 2018 and recent updates occuring as recently as February 3rd 2022.

Q: Are participants older than 40 being considered for this experiment?

Eligible patients for this research must fall in the 25 to 65 age range. 206 trials aimed at those below 18 are being conducted and 670 studies targeting seniors above 65 years old are ongoing.

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

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.

Eligible Conditions

Cardiovascular Risk
Circadian Dysregulation
Obesity

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

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

11C-CGP12177

2018

Completed Early Phase 1

~20

PET Imaging

2008

Completed Phase 3

~380

Circadian Study Protocol

2018

Completed Early Phase 1

~20

11C-Meta-Hydroxyephedrine (mHED)

2018

Completed Early Phase 1

~20

O15-water

2018

Completed Early Phase 1

~20

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

978 Previous Clinical Trials

7,386,488 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can be accepted into the cohort of this trial?

"This clinical trial is aiming to involve 28 individuals aged between 25 and 65 who are struggling with obesity. Eligible participants must also fall within the BMI range of 18.5 - 40kg/m2, while being habitually sedentary."

Answered by AI

What is the upper limit on the number of participants for this investigation?

"Yes, the clinical trial is still open for enrollment. The initial post was made on May 1st 2018 with a subsequent update occurring on February 3rd 2022. Presently, 28 volunteers are needed from one centre."

Answered by AI

Is recruitment for this test still taking place?

"According to clinicaltrials.gov, this review is actively recruiting patients with the initial posting appearing on May 1st 2018 and recent updates occuring as recently as February 3rd 2022."

Answered by AI

Are participants older than 40 being considered for this experiment?

"Eligible patients for this research must fall in the 25 to 65 age range. 206 trials aimed at those below 18 are being conducted and 670 studies targeting seniors above 65 years old are ongoing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Body Weight, Sleep, and Heart Health

Steven A. Shea 2018. "Body Weight, Sleep, and Heart Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03388788.