Lichaamsgewicht, slaap en hartgezondheid
Circadiane mechanismen van cardiovasculair risico bij obesitas
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Oregon
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Portland, Oregon, Verenigde Staten, 97239
- Oregon Health & Science University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Community sample
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: OTHER
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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). |
Drugs are used for as part of physiological monitoring and not as interventions, including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).
Andere namen:
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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). |
Drugs are used for as part of physiological monitoring and not as interventions, including imaging using radiopharmaceuticals (11C-meta-hydroxyephedrine, and 11C-CGP12177).
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Blood Pressure (BP)
Tijdsspanne: 5 Days
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Coronary Microvascular Blood Flux
Tijdsspanne: 3 days
|
Coronary microvascular function, measured as coronary microvascular blood flux using myocardial contrast echocardiography. |
3 days
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Flow Mediated Dilation (FMD)
Tijdsspanne: 5 days
|
FMD to measure endothelial function. |
5 days
|
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Heart Rate
Tijdsspanne: 5 Days
|
Heart rate via 2-channel echocardiogram (ECG) |
5 Days
|
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Epinephrine
Tijdsspanne: 5 days
|
Venous Epinephrine to estimate sympathetic output |
5 days
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Norepinephrine
Tijdsspanne: 5 days
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Venous Norepinephrine to estimate sympathetic output |
5 days
|
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Cortisol
Tijdsspanne: 5 days
|
Saliva cortisol to estimate sympathetic output |
5 days
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Beta-adrenergic Receptor Density (Exploratory Outcome)
Tijdsspanne: 5 days.
|
Radiolabeled agonist (11C-CGP12177) to measure beta-adrenergic receptors during PET Imaging. |
5 days.
|
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Norepinephrine Reuptake Transport (Exploratory Outcome)
Tijdsspanne: 5 days.
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Radiolabeled meta-hydroxyephedrine (11C-mHED) to measure norepinephrine reuptake during PET Imaging. |
5 days.
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Steven A Shea, PhD, Oregon Institute of Occupational Health Sciences
- Hoofdonderzoeker: Jeanne M Link, PhD, OHSU Center for Radiochemistry Research
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het zenuwstelsel
- Voedingsstoornissen
- Overvoeding
- Lichaamsgewicht
- Overgewicht
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Tekenen en symptomen
- Obesitas
- Chronobiologische stoornissen
- Onderzoekstechnieken
- Chemie -technieken, analytisch
- Spectrumanalyse
- Magnetische resonantiespectroscopie
- 2-fenyl-6- (2 '-(4'-(ethoxycarbonyl) thiazolyl)) thiazolo (3,2-b) (1,2,4) triazol
Andere studie-ID-nummers
- IRB00017489
- KL2TR002370 (Subsidie/contract van de Amerikaanse NIH)
- R01HL140577 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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