The Physiology of Fatigue in Patients With Chronic Liver Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier:
NCT01867385
First received: May 31, 2013
Last updated: April 2, 2014
Last verified: March 2014
  Purpose

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.

Condition
Liver Disease

Study Type: Observational
Official Title: The Physiology of Fatigue in Patients With Chronic Liver Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Circadian rythms [ Time Frame: 2-7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01867385

Contacts
Contact: Nevitt V Morris, R.N. (301) 496-1665 nevitt.morris@nih.gov
Contact: Yaron Rotman, M.D. (301) 451-6553 rotmanyaron@mail.nih.gov

Locations
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    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Yaron Rotman, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT01867385     History of Changes
Other Study ID Numbers: 130142, 13-DK-0142
Study First Received: May 31, 2013
Last Updated: April 2, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Fatigue
Chronic Hepatitis
Chronic Hepatitis B
Chronic Hepatitis C
Hepatitis

Additional relevant MeSH terms:
Fatigue
Liver Diseases
Digestive System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014