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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK124280 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Lab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7-day sleep lab | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment | 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 | 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. |
| Change in Intestinal Permeability From Baseline (Aligned Circadian Rhythms) 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24 Hour Urinary Melatonin Concentrations From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment | Spectrophotometry | 24 hour urine collection at baseline and 24 hour urine collection at circadian misalignment circadian |
| Change in Mayo Score From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment |
| Measure | Description | Time Frame |
|---|---|---|
| Diet | 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. | Once before sleep lab |
Inclusion Criteria:
UC patients:
Healthy Controls:
Exclusion Criteria:
UC patients:
Healthy Controls:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Control | 7-day sleep lab: Healthy Control participants (no ulcerative Colitis) will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not have a misaligned circadian rhythm. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection at baseline and after misalignment. 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. |
| FG001 | Ulcerative Colitis | 7-day sleep lab: Participants with ulcerative colitis will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not have a misaligned circadian rhythm. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection at baseline and after misalignment. 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Control | 7-day sleep lab: Healthy Control participants (no ulcerative colitis) will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not have a misaligned circadian rhythm. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection at baseline and after misalignment. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment | 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 | Posted | Mean | Standard Deviation | hours | 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. |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Controls | 7-day sleep lab: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Garth Swanson | Medical University of South Carolina | 843-876-2152 | swansong@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2024 | Jun 19, 2025 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 2, 2023 | Jun 3, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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40 human subjects will be recruited into this proposed study: 20 Healthy Controls and 20 UC subjects with left sided inactive disease. Patients will be matched with Health Controls. Patients will have two study visits: the first is the initial in-clinic screening and the second is the 7-day sleep lab intervention. There will be no follow-up after the lab.
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|
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. |
| 30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment |
| Change in Stool Calprotectin From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment | Calprotectin is a sensitive marker for inflammation in the gastrointestinal tract. Measured through enzyme linked immunosorbent assay for calprotectin in stool extract. | 10 minute stool collection conducted at baseline circadian rhythm and at circadian misalignment. |
| Change in Concentration of Serum Cytokine Markers of Inflammation From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment | Enzyme linked immunosorbent assay | 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 |
| Changes in Clock Gene Expression in Peripheral Blood Mononuclear Cells From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment | RNA Sequencing | 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 |
| Changes in Gene Expression of Colonic Tissue Biopsies From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment | Tissue biopsies collected during flexible sigmoidoscopy conducted at Baseline Circadian Rhythm and at Circadian Misalignment. Assessed through histology and RNA Sequencing | 30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment |
| Single Day Food Recall | Automated Self-Administered 24-Hour Recall (ASA24) Dietary Assessment. Total nutrients from all supplements reported in a given day. | Once before sleep lab |
| Chronotype | 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. | Screening |
| Beck Depression Inventory | 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. | 3 Weeks prior to circadian lab assessments |
| Pittsburgh Sleep Quality Index | The following questions relate to your usual sleep habits during the past month only. | 3 Weeks prior to circadian lab assessments |
| BG001 | Ulcerative Colitis | 7-day sleep lab: Participants with ulcerative colitis will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not have a misaligned circadian rhythm. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection at baseline and after misalignment. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Ulcerative Colitis | 7-day sleep lab: Participants with ulcerative colitis will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not a have a misaligned circadian rhythm. 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 |
|
|
| Primary | Change in Intestinal Permeability From Baseline (Aligned Circadian Rhythms) 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. | Posted | Mean | Standard Deviation | % excretion of oral dose 12-24 hr urinar | 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 |
|
|
|
| Secondary | Change in 24 Hour Urinary Melatonin Concentrations From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment | Spectrophotometry | Not Posted | 24 hour urine collection at baseline and 24 hour urine collection at circadian misalignment circadian | Participants |
| Secondary | Change in Mayo Score From Baseline (Aligned Circadian Rhythms) to 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. | Not Posted | 30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment | Participants |
| Secondary | Change in Stool Calprotectin From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment | Calprotectin is a sensitive marker for inflammation in the gastrointestinal tract. Measured through enzyme linked immunosorbent assay for calprotectin in stool extract. | Not Posted | 10 minute stool collection conducted at baseline circadian rhythm and at circadian misalignment. | Participants |
| Secondary | Change in Concentration of Serum Cytokine Markers of Inflammation From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment | Enzyme linked immunosorbent assay | Not Posted | 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 | Participants |
| Secondary | Changes in Clock Gene Expression in Peripheral Blood Mononuclear Cells From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment | RNA Sequencing | Not Posted | 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 | Participants |
| Secondary | Changes in Gene Expression of Colonic Tissue Biopsies From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment | Tissue biopsies collected during flexible sigmoidoscopy conducted at Baseline Circadian Rhythm and at Circadian Misalignment. Assessed through histology and RNA Sequencing | Not Posted | 30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment | Participants |
| Other Pre-specified | Diet | 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. | Not Posted | Once before sleep lab | Participants |
| Other Pre-specified | Single Day Food Recall | Automated Self-Administered 24-Hour Recall (ASA24) Dietary Assessment. Total nutrients from all supplements reported in a given day. | Not Posted | Once before sleep lab | Participants |
| Other Pre-specified | Chronotype | 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. | Not Posted | Screening | Participants |
| Other Pre-specified | Beck Depression Inventory | 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. | Not Posted | 3 Weeks prior to circadian lab assessments | Participants |
| Other Pre-specified | Pittsburgh Sleep Quality Index | The following questions relate to your usual sleep habits during the past month only. | Not Posted | 3 Weeks prior to circadian lab assessments | Participants |
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Ulcerative Colitis | 7-day sleep lab: 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |