The Physiology of Fatigue in Patients With Chronic Liver Disease
- Fatigue is a common and often disabling symptom in people with chronic liver disease. Its causes are not well understood. Sleep disturbance may play a role in people with cirrhosis, but these factors have not been studied in people with other stages of liver disease. This study will look at the body's circadian rhythms (internal clock) to see if problems with these rhythms can contribute to fatigue. It will look at the causes and mechanisms of fatigue in people with chronic liver disease by comparing people with and without fatigue.
- To study reasons for fatigue in people with chronic liver disease.
- < TAB> Individuals at least 18 years of age who have chronic liver disease.
- < TAB> Participants with or without fatigue may enroll.
- Participants will be screened with a physical exam and medical history. They will have a 2-day inpatient stay for the study.
- For the 7 days before the inpatient stay, participants will keep a sleep diary. They will record any caffeine or alcohol consumption, medicines, exercise, and sleep or naps. They will also wear an actigraph to measure their activity levels.
- During the inpatient stay, participants will answer questions about fatigue and sleep habits. They will have regular blood tests for 24 hours. Their body temperature will also be monitored. During the night, they will have a sleep study to look at how well or poorly they sleep.
- Treatment will not be provided as part of this study.
|Official Title:||The Physiology of Fatigue in Patients With Chronic Liver Disease|
- Circadian rythms [ Time Frame: 2-7 days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Fatigue is a common symptom in patients with chronic liver disease, and can severely impact quality of life. Thus far, there is scant knowledge about the causes of fatigue in this population, and almost no specific treatments for fatigue have been found effective in clinical trials. Sleep disturbance and alterations in plasma melatonin profiles have been documented in patients with cirrhosis, but remain largely unstudied in patients with earlier stages of liver disease. Up to 50 patients will be enrolled in a case-control study on the physiology of fatigue in patients with chronic liver disease. This is a descriptive study, exploring the concept that fatigue may be the result of circadian rhythms in the central nervous system being out of sync with circadian rhythms in peripheral organs, i.e. unsynchronized central and peripheral clocks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01867385
|Contact: Nevitt V Morris, R.N.||(301) firstname.lastname@example.org|
|Contact: Yaron Rotman, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Yaron Rotman, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|