Body Weight, Sleep, and Heart Health

NCT03388788 | Active Not Recruiting Results FDA Drug

• 3 other identifiers: IRB00017489R01HL140577KL2TR002370
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Risk Factor; Circadian Dysregulation; Obesity

Outcome Measures

Primary Outcomes (1)

• Blood Pressure (BP)

  Measurements were collected up to 7 times per participant across the circadian cycle under constant conditions across 5 days. Resting BP and Exercise BP data were collected at the beginning of each of 7 wake periods in a supine position and where participants exercised at an intensity equivalent to brisk walking. Salivary melatonin was used to calculate the circadian phase marker using dim light melatonin onset (DLMO). All data were assigned a circadian phase relative to DLMO and binned into 4-hour (or 60-degree) intervals. In the statistical analysis, the weight group refers to normal or overweight, exercise condition refers to seated or exercising on the bike, and circadian phase refers to the center of the circadian bin. This is an observational study. Due to insufficient enrollment and an imbalanced group distribution, we do not have sufficient statistical power to fully interpret these data. The data are valuable as pilot data for future investigations and sample size estimation.

  5 Days

Secondary Outcomes (6)

• Coronary Microvascular Blood Flux

  3 days

• Flow Mediated Dilation (FMD)

  5 days

• Heart Rate

  5 Days

• Epinephrine

  5 days

• Norepinephrine

  5 days

Other Outcomes (2)

• Beta-adrenergic Receptor Density (Exploratory Outcome)

  5 days.

• Norepinephrine Reuptake Transport (Exploratory Outcome)

  5 days.

Study Arms (2)

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).

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

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).

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

Interventions

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

Also known as: PET scanning

Normal Weight; Overweight

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, saliva

MeSH Terms

Conditions

Chronobiology Disorders; Obesity

Interventions

Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

For the exploratory aim, the complex circadian PET protocol was operationally challenging and only partially completed. Short tracer half-lives, lack of automation, tight timing, and overnight chemistry variability caused synthesis issues; plus COVID and staff loss constrained execution. Of 895 screened, 16 enrolled, with no complete datasets. Thus, statistical power and interpretation are limited. These data serve as pilot data; future feasibility will require more personnel, and automation.

Results Point of Contact

• Title: Steven A Shea
• Organization: Oregon Institute of Occupational Health Sciences, OHSU

sheast@ohsu.edu

5034942517

Study Officials

• Steven A Shea, PhD

  Oregon Institute of Occupational Health Sciences

  PRINCIPAL INVESTIGATOR

• Jeanne M Link, PhD

  OHSU Center for Radiochemistry Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 3, 2018
• Study Start: May 1, 2018
• Primary Completion: September 30, 2024
• Study Completion: June 30, 2026
• Last Updated: May 18, 2026
• Results First Posted: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)