Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Restoring Molecular Circadian Rhythm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04086589
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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, we propose to use such blood samples to "age" circadian rhythms in cultured cells. We will verify aged blood-dependent alteration of rhythms and then conduct molecular screens to reverse this decline. If we identify specific genes that can restore molecular circadian rhythm in vitro, we will explore these in animal models (Drosophila, mouse).

Condition or disease Intervention/treatment
Healthy Young Healthy Elderly Other: Observational study without intervention

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Exploratory Pilot Study to Discover Genes That Restore the Molecular Circadian Rhythm
Actual Study Start Date : August 18, 2019
Estimated Primary Completion Date : August 17, 2021
Estimated Study Completion Date : August 17, 2022

Group/Cohort Intervention/treatment
Young
Observational study without intervention
Other: Observational study without intervention
Observational study without intervention

Elderly
Observational study without intervention
Other: Observational study without intervention
Observational study without intervention




Primary Outcome Measures :
  1. 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 Frame: Time point 14:00 Hours ]
    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

  2. 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 Frame: Time point 14:00 Hours ]
    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)


Secondary Outcome Measures :
  1. Chronotype [ Time Frame: 4 weeks ]
    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

  2. Acrophase [ Time Frame: 7 days ]
    Clock hour of peak physical activity averaged from 7 or more days of actigraphy

  3. Physical activity [ Time Frame: 7 days ]
    Vector magnitude of physical activity averaged from 7 or more days of actigraphy

  4. Sleep quantity [ Time Frame: 7 or more days ]
    Hours of sleep averaged from 7 or more days of actigraphy

  5. Sleep quality: actigraphy [ Time Frame: 7 days ]
    Sleep fragmentation averaged from 7 or more days of actigraphy

  6. Ambient light exposure [ Time Frame: 7 days ]
    Ambient light exposure averaged from 7 or more days of actigraphy

  7. Heart rate variability [ Time Frame: 24 hours ]
    Heart rate variability (RR intervals) averaged from 24 hours of BioPatch

  8. Saliva cortisol [ Time Frame: 24 hours ]
    Difference in concentrations of cortisol measured in saliva between morning versus evening



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Apparent healthy volunteers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086589


Contacts
Layout table for location contacts
Contact: LaVenia Banas 215-662-4652 banas@pennmedicine.upenn.edu
Contact: Jessica Hunter 215-898-2799 nhunter@pennmedicine.upenn.edu

Locations
Layout table for location information
United States, Pennsylvania
University of Pennsylvania School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lavenia Banas, CRN    215-662-4652    banas@pennmedicine.upenn.edu   
Contact: Carsten Skarke, M.D.    215-573-0673    cskarke@pennmedicine.upenn.edu   
Principal Investigator: Carsten Skarke, M.D.         
Principal Investigator: Jessica Schwarz         
Principal Investigator: Amita Sehgal, PhD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Carsten Skarke, MD University of Pennsylvania

Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04086589     History of Changes
Other Study ID Numbers: 832866
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
healthy, young, elderly