Rush University Medical Center
Chicago, Illinois, 60612, United States
NCT Number: NCT05180279
The purpose of this study is to investigate if circadian malalignment (unusual sleeping patterns), such as night shifts (sleeping during the day and being awake during the night time), worsens the inflammation of the gut. We hope to look at patients with Ulcerative Colitis and Healthy Controls.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
UC patients:
Healthy Controls:
Exclusion criteria
UC patients:
Healthy Controls:
Patients will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection. Cycles will be shifted by 12h once on Day 3 of sleep lab and be discharged after an 8 hour sleep session on Day 7.
Time frame: Blood is drawn every hour over 8 hours to measure plasma melatonin in dim light < 5 lux in Aligned Circadian Rhythms, and blood is drawn every hour for 12 hours under dim light in Misaligned Circadian rhythms.
Amount of time between dim light melatonin onset (DLMO) to sleep onset. The hours reported for this outcome measure equates the time of the day the participant fell asleep
Time frame: 24 hour urine collection beginning at baseline and 24 hour urine collection at circadian misalignment, an average of 3 days from baseline to circadian misalignment
Intestinal permeability is assessed through spectrophotometric measurements of sucralose, sucrose, maltose and lactulose concentrations in urine following ingestion of a sugar cocktail.
Time frame: 24 hour urine collection at baseline and 24 hour urine collection at circadian misalignment circadian
Spectrophotometry
Time frame: 30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment
Within the endoscopic component of the Mayo Score, a score of 0 is given for normal mucosa or inactive UC, while a score of 1 is given for mild disease with evidence of mild friability, reduced vascular pattern, and mucosal erythema.
Time frame: 10 minute stool collection conducted at baseline circadian rhythm and at circadian misalignment.
Calprotectin is a sensitive marker for inflammation in the gastrointestinal tract. Measured through enzyme linked immunosorbent assay for calprotectin in stool extract.
Time frame: Blood is drawn every two hours over a 24 hour period at baseline (12 draws), and blood is drawn every two hours over a 24 hour period at circadian misalignment
Enzyme linked immunosorbent assay
Time frame: Blood is drawn every two hours over a 24 hour period at baseline (12 draws), and blood is drawn every two hours over a 24 hour period at circadian misalignment
RNA Sequencing
Time frame: 30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment
Tissue biopsies collected during flexible sigmoidoscopy conducted at Baseline Circadian Rhythm and at Circadian Misalignment. Assessed through histology and RNA Sequencing
Time frame: Once before sleep lab
Vioscreen Food Frequency Questionnaire (FFQ). Total of 19 measured food components. Vioscreen captures comprehensive dietary behaviors in just 30 minutes. It is a unique dietary questionnaire, management and analysis system that efficiently gathers and manages data that immediately identifies dietary "habits" and counsel for lifestyle changes.
Time frame: Once before sleep lab
Automated Self-Administered 24-Hour Recall (ASA24) Dietary Assessment. Total nutrients from all supplements reported in a given day.
Time frame: Screening
The Munich ChronoType Questionnaire (MCTQ) uses a self-rated scale to assess individual phase of entrainment on work and work-free days; it is a tool to collect primary sleep times, such as bed- and rise-times, plus the clock time of becoming fully awake as well as sleep latency and inertia, in addition to other time points.
Time frame: 3 Weeks prior to circadian lab assessments
The Beck Depression Inventory (BDI, BDI-II), created by Dr. Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.
Time frame: 3 Weeks prior to circadian lab assessments
The following questions relate to your usual sleep habits during the past month only.
Rush University Medical Center
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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