Status:
COMPLETED
The Physiology of Fatigue in Patients With Chronic Liver Disease
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Liver Disease
Eligibility:
All Genders
18+ years
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, bu...
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 almo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 31 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 20 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01867385
Start Date
May 31 2013
End Date
November 20 2018
Last Update
November 23 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892