The Physiology of Fatigue in Patients With Chronic Liver Disease
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01867385|
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : November 22, 2018
- 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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||The Physiology of Fatigue in Patients With Chronic Liver Disease|
|Study Start Date :||May 31, 2013|
|Actual Primary Completion Date :||September 11, 2015|
|Actual Study Completion Date :||November 20, 2018|
- Circadian rythms [ Time Frame: 2-7 days ]
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): NCT01867385
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Yaron Rotman, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|