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Restoring Molecular Circadian Rhythm

Exploratory Pilot Study to Discover Genes That Restore the Molecular Circadian Rhythm

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04086589
Enrollment
40
Registered
2019-09-11
Start date
2019-08-19
Completion date
2028-11-01
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Elderly, Healthy Young

Keywords

healthy, young, elderly

Brief summary

The goal is to address the mechanisms that account for alteration of circadian rhythms with age. As the blood of aged individuals can produce this alteration, the investigators propose to use such blood samples to "age" circadian rhythms in cultured cells. The investigators will verify aged blood-dependent alteration of rhythms and then conduct molecular screens to reverse this decline. If the investigators identify specific genes that can restore molecular circadian rhythm in vitro, the investigators will explore these in animal models (Drosophila, mouse).

Interventions

Observational study without intervention

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* General good health with the following conditions permissible * cardiovascular risk prevention, intake of low dose aspirin, * hypertension, intake of beta-blockers, ACE inhibitors, diuretics, calcium channel blockers * hypercholesterinemia, intake of statins * Cases: 70-85 years of age * Controls: 20-35 years of age * Patients must be able to read and understand English * Participants must sign the informed consent form * Participants must have a wrist-actigraphy-based average TST (total sleep time) ≥ 6 hours per night (measured over 7 consecutive days) occurring between 22:00 - 08:00

Exclusion criteria

* Known history of severe psychiatric or cognitive conditions, for example mania, schizophrenia, or mental retardation * Shift work, defined as recurring work between 22:00-05:00 * History of clinically significant obstructive sleep apnea * Transmeridian travel across ≥2 time zones in the two weeks prior to the blood draws and one week after, * \> 2 drinks of alcohol per day * Use of illicit drugs

Design outcomes

Primary

MeasureTime frameDescription
Delta of period length measured in hh:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)Time point 14:00 HoursTo determine if serum collected from young versus old healthy study participants have a differential effect on the expression of circadian rhythms in an in vitro culture of a fibroblast cell line
Delta of phase measured in HH:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)Time point 14:00 HoursThe primary endpoint will be the difference in phase angle in vitro between cycling fibroblasts and incubated with serum collected from cases (old adults) versus controls (young adults)

Secondary

MeasureTime frameDescription
Chronotype4 weeksAssessed per survey; chronotypes per Munich Chronotype questionnaire are extreme early type, moderate early type, slight early type, normal type, slight late type, moderate late type, extreme late type
Acrophase7 daysClock hour of peak physical activity averaged from 7 or more days of actigraphy
Physical activity7 daysVector magnitude of physical activity averaged from 7 or more days of actigraphy
Sleep quantity7 or more daysHours of sleep averaged from 7 or more days of actigraphy
Sleep quality: actigraphy7 daysSleep fragmentation averaged from 7 or more days of actigraphy
Ambient light exposure7 daysAmbient light exposure averaged from 7 or more days of actigraphy
Heart rate variability24 hoursHeart rate variability (RR intervals) averaged from 24 hours of BioPatch
Saliva cortisol24 hoursDifference in concentrations of cortisol measured in saliva between morning versus evening

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCarsten Skarke, MD

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026