Identification of Novel Circadian Biomarkers

NCT02291003 | Completed

• 1 other identifier: STU00096215
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Circadian clocks are not only found in discrete areas of the brain, but are found in virtually every organ in our bodies, including the heart, lungs and immune system. Disruptions in circadian clocks, or chronopathology, may underlie various forms of cardiovascular, pulmonary, and metabolic disorders. Over the past two decades, molecular geneticists have "cracked" the clock to reveal its core biochemical mechanisms evident in organisms from fruit flies to humans. These mechanistic insights have led to the discovery of links between clock function and an ever-expanding array of prevalent diseases, including heart, lung, metabolic and sleep disorders. Yet the prevalence of circadian disruption in these patient populations is unclear because current tests are not easily applied in clinical settings or have yet to be developed. Here the investigators exploit our newfound understanding of clock mechanisms and the development of new genomic technologies to identify novel complements of clock-regulated genes ("signatures") that will reveal the state of the internal biological clock. This approach will allow us to take a genomic snapshot of clock status from a single blood draw, substantially easing the diagnosis of these individuals with evidence of circadian disruption or misalignment, i.e., chronopathology.

Conditions

Circadian Rhythm Disorders

Keywords

circadian; sleep

Outcome Measures

Primary Outcomes (1)

• Circadian gene expression profile

  The circadian pattern of gene expression will be determined through collecting saliva and blood at regular intervals over a 24 hour and analyzing with microarrays.

  1 day

Study Arms (1)

Healthy controls

Healthy controls -observational, no intervention administered.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy controls, age 18-60 with habitual sleep

You may qualify if:

• Healthy controls
• Age 18-60
• Intermediate circadian chronotype as determined by the Horne-Ostberg and Munich questionnaire
• Habitual sleep start times between 9:30pm and 1am
• Habitual sleep duration of 6-9 hours

You may not qualify if:

• History or current Diagnostic and Statistical Manual-V major psychiatric disorder
• Use of psychoactive medications
• Beck Depression inventory ≥ 16 indicating possible depression
• A history or current diagnosis of a primary sleep disorder (insomnia, sleep apnea, circadian rhythm sleep disorder, restless legs)
• Shift work or other types of self-imposed irregular sleep/wake cycles
• History of, or concurrent unstable or serious medical illness
• Allergy to heparin
• Blindness or other visual impairment other than glasses

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva and skin samples

MeSH Terms

Conditions

Chronobiology Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Phyllis C Zee, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Benjamin and Virginia T. Boshes Professor of Neurology

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 14, 2014
• Study Start: January 29, 2015
• Primary Completion: December 16, 2015
• Study Completion: September 30, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)