The Physiology of Fatigue in Patients With Chronic Liver Disease

NCT01867385 | Completed

• 2 other identifiers: 13014213-DK-0142
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Disease

Keywords

Fatigue; Chronic Hepatitis; Chronic Hepatitis B; Chronic Hepatitis C; Hepatitis

Outcome Measures

Primary Outcomes (1)

• Circadian rythms

  2-7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age \>18) with chronic liver disease of any etiology

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 9425939 BACKGROUND

• 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.

  PMID: 7677303 BACKGROUND

• 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.

  PMID: 17406828 BACKGROUND

MeSH Terms

Conditions

Liver Diseases; Fatigue; Hepatitis, Chronic; Hepatitis B, Chronic; Hepatitis C, Chronic; Hepatitis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis C; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Yaron Rotman, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 4, 2013
• Study Start: May 31, 2013
• Primary Completion: September 11, 2015
• Study Completion: November 20, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11-20

Locations

US (1)