Kroppsvekt, søvn og hjertehelse
Cirkadiske mekanismer for kardiovaskulær risiko ved fedme
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.
Studieoversikt
Status
Detaljert beskrivelse
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health & Science University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Community sample
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: OTHER
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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).
Andre navn:
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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).
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Blood Pressure (BP)
Tidsramme: 5 Days
|
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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Coronary Microvascular Blood Flux
Tidsramme: 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)
Tidsramme: 5 days
|
FMD to measure endothelial function. |
5 days
|
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Heart Rate
Tidsramme: 5 Days
|
Heart rate via 2-channel echocardiogram (ECG) |
5 Days
|
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Epinephrine
Tidsramme: 5 days
|
Venous Epinephrine to estimate sympathetic output |
5 days
|
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Norepinephrine
Tidsramme: 5 days
|
Venous Norepinephrine to estimate sympathetic output |
5 days
|
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Cortisol
Tidsramme: 5 days
|
Saliva cortisol to estimate sympathetic output |
5 days
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Beta-adrenergic Receptor Density (Exploratory Outcome)
Tidsramme: 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)
Tidsramme: 5 days.
|
Radiolabeled meta-hydroxyephedrine (11C-mHED) to measure norepinephrine reuptake during PET Imaging. |
5 days.
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Steven A Shea, PhD, Oregon Institute of Occupational Health Sciences
- Hovedetterforsker: Jeanne M Link, PhD, OHSU Center for Radiochemistry Research
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Ernæringsforstyrrelser
- Overernæring
- Kroppsvekt
- Overvektig
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Overvekt
- Kronobiologiske lidelser
- Undersøkelsesteknikker
- Kjemisteknikker, analytisk
- Spektrumanalyse
- Magnetisk resonansspektroskopi
- 2-fenyl-6- (2 '-(4'-(etoksykarbonyl) tiazolyl)) tiazolo (3,2-B) (1,2,4) triazol
Andre studie-ID-numre
- IRB00017489
- KL2TR002370 (U.S. NIH-stipend/kontrakt)
- R01HL140577 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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