Restoring Molecular Circadian Rhythm

Healthy Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04086589
• Other study ID #: 832866
• Status: Suspended
• Start date: August 19, 2019
• Est. completion date: December 17, 2024

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: December 17, 2024
• Est. primary completion date: July 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Elderly
• Healthy Young

Intervention

Other:
• Observational study without intervention
Observational study without intervention

Locations

Country	Name	City	State
United States	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	To 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	Time point 14:00 Hours
Primary	Delta of phase measured in HH:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)	The 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)	Time point 14:00 Hours
Secondary	Chronotype	Assessed 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	4 weeks
Secondary	Acrophase	Clock hour of peak physical activity averaged from 7 or more days of actigraphy	7 days
Secondary	Physical activity	Vector magnitude of physical activity averaged from 7 or more days of actigraphy	7 days
Secondary	Sleep quantity	Hours of sleep averaged from 7 or more days of actigraphy	7 or more days
Secondary	Sleep quality: actigraphy	Sleep fragmentation averaged from 7 or more days of actigraphy	7 days
Secondary	Ambient light exposure	Ambient light exposure averaged from 7 or more days of actigraphy	7 days
Secondary	Heart rate variability	Heart rate variability (RR intervals) averaged from 24 hours of BioPatch	24 hours
Secondary	Saliva cortisol	Difference in concentrations of cortisol measured in saliva between morning versus evening	24 hours