Restoring Molecular Circadian Rhythm

NCT ID: NCT04086589

Last Updated: 2026-01-23

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

SUSPENDED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-19

Study Completion Date

2028-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Healthy Young Healthy Elderly

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Young

Observational study without intervention

Observational study without intervention

Intervention Type OTHER

Observational study without intervention

Elderly

Observational study without intervention

Observational study without intervention

Intervention Type OTHER

Observational study without intervention

Interventions

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Observational study without intervention

Observational study without intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carsten Skarke, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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832866

Identifier Type: -

Identifier Source: org_study_id

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