- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01867385
The Physiology of Fatigue in Patients With Chronic Liver Disease
Background:
- 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.
Objectives:
- To study reasons for fatigue in people with chronic liver disease.
Eligibility:
- <TAB>Individuals at least 18 years of age who have chronic liver disease.
- <TAB>Participants with or without fatigue may enroll.
Design:
- 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
- Adults (age >18) with chronic liver disease of any etiology
EXCLUSION CRITERIA:
- Treatment with medications or supplements frequently associated with fatigue, such as interferon (within the last four months), beta-blockers, calcium channel blockers, benzodiazepines, sedating antihistamines, antidepressants, antipsychotics, or melatonin. In select instances, patients using these medications may be enrolled if, in the opinion of the investigators, their fatigue is clearly unrelated to the medication.
- Untreated or uncontrolled comorbidities that influence fatigue, including thyroid disorders (TSH>5 mcIU/mL), anemia (Hemoglobin<11 g/dL), major depression, active substance abuse or other conditions as determined by the enrolling physician. Comorbidities that are adequately controlled will not exclude patients.
- Untreated sleep disorders such as obstructive sleep apnea or restless leg syndrome
- Decompensated cirrhosis (encephalopathy, gastrointestinal bleeding, ascites, bilirubin >2) within the last six months
- Patients planning to travel outside the time zone during the study period
- Known or suspected significant gastrointestinal motility disorder, obstruction, or structuring disease
- Pregnancy, breastfeeding, or intention to become pregnant
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Circadian rythms
Time Frame: 2-7 days
|
2-7 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Foster GR, Goldin RD, Thomas HC. Chronic hepatitis C virus infection causes a significant reduction in quality of life in the absence of cirrhosis. Hepatology. 1998 Jan;27(1):209-12. doi: 10.1002/hep.510270132.
- Gumber SC, Chopra S. Hepatitis C: a multifaceted disease. Review of extrahepatic manifestations. Ann Intern Med. 1995 Oct 15;123(8):615-20. doi: 10.7326/0003-4819-123-8-199510150-00008.
- Kallman J, O'Neil MM, Larive B, Boparai N, Calabrese L, Younossi ZM. Fatigue and health-related quality of life (HRQL) in chronic hepatitis C virus infection. Dig Dis Sci. 2007 Oct;52(10):2531-9. doi: 10.1007/s10620-006-9708-x. Epub 2007 Apr 4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 130142
- 13-DK-0142
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Disease
-
HaEmek Medical Center, IsraelTerminatedPatients With Fatty Liver DiseaseIsrael
-
Assistance Publique - Hôpitaux de ParisCompletedNonalcoholic Fatty Liver Disease (NAFLD)France
-
Massachusetts General HospitalCompletedNonalcoholic Fatty Liver Disease (NAFLD)United States
-
Columbia UniversityGlaxoSmithKlineCompletedNon-Alcoholic Fatty Liver DiseaseUnited States
-
Kowa Company, Ltd.CompletedNon-Alcoholic Fatty Liver DiseaseJapan
-
Saluz Investigación S. C.RecruitingMetabolic Associated Fatty Liver DiseaseMexico
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Not yet recruitingMetabolic Associated Fatty Liver Disease
-
Nanfang Hospital of Southern Medical UniversityRecruitingMetabolic Associated Fatty Liver DiseaseChina
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...RecruitingMetabolic Associated Fatty Liver Disease | Clinical FeaturesChina
-
Chinese PLA General HospitalCompletedMetabolic-dysfunction-associated Fatty Liver Disease (MAFLD)China