Body Weight, Sleep, and Heart Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Risk Factor Circadian Dysregulation Obesity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Weight

Healthy lean controls \[18.5\<BMI\<25 kg/m2 and waist circumference \<94/80 cm (men/women respectively)\] will participate in a 5-day circadian study protocol with numerous repeated cardiovascular measures across the circadian cycle. Drugs are used as part of physiological monitoring and not as interventions including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).

Positron Emission Tomography (PET) scanning of cardiac function at 3 time points across the 24 hour circadian cycle

Intervention Type COMBINATION_PRODUCT

Drugs are used for as part of physiological monitoring and not as interventions, including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).

Overweight

Healthy obese \[30≤BMI\<40 and waist circumference ≥94/80 (men and women respectively)\] Healthy lean controls \[18.5\<BMI\<25 kg/m2 and waist circumference \<94/80 cm (men/women respectively)\] will participate in a 5-day circadian study protocol with numerous repeated cardiovascular measures across the circadian cycle. Drugs are used as part of physiological monitoring and not as interventions including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).

Positron Emission Tomography (PET) scanning of cardiac function at 3 time points across the 24 hour circadian cycle

Intervention Type COMBINATION_PRODUCT

Drugs are used for as part of physiological monitoring and not as interventions, including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).

Interventions

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Positron Emission Tomography (PET) scanning of cardiac function at 3 time points across the 24 hour circadian cycle

Drugs are used for as part of physiological monitoring and not as interventions, including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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PET scanning

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* History of smoking/tobacco use
* Insomnia
* 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)

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes