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

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 31, 2013

Primary Completion (Actual)

September 11, 2015

Study Completion (Actual)

November 20, 2018

Study Registration Dates

First Submitted

May 31, 2013

First Submitted That Met QC Criteria

May 31, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Actual)

November 23, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

November 20, 2018

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.

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