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Autonomic Dysfunction in Non-Alcoholic Fatty Liver Disease (AD-NAFLD)

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ClinicalTrials.gov Identifier: NCT02132780
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
There is a significant association between autonomic dysfunction and symptoms experienced by NAFLD patients mediated by increased systemic inflammation and insulin resistance, resulting in deteriorating quality of life of affected patients; fatigue and other symptoms drive worsening autonomic dysfunction in these patients. We aim to describe the severity of autonomic dysfunction (AD) in non-alcoholic fatty liver disease (NAFLD) and the relationship of AD to symptoms experienced by NAFLD patients (such as fatigue, chronic pain, depression, sleep disturbance, and cognitive dysfunction), and to the quality of life of NAFLD patients. We also hope to examine the impact of systemic inflammation and insulin resistance as mediators of manifestations of AD and symptoms experienced by NAFLD patients.

Condition or disease
Non-alcoholic Fatty Liver Disease NAFLD Fatty Liver, Nonalcoholic Nonalcoholic Fatty Liver Disease

Detailed Description:

Aim 1. Describe the severity of AD in NAFLD and the relationship of AD to symptoms experienced by NAFLD patients (fatigue, chronic pain, depression, sleep disturbance, and cognitive dysfunction) (Aim 1a) and to the quality of life of NAFLD patients (Aim 1b). Primary screening for inclusion/exclusion criteria will be done at the VCUHS clinic. Subjects meeting inclusion criteria will be approached about study participation during their routine NAFLD clinic visit. Those who agree to participate in the study will return for a study visit at the CCTR Clinical Research Services. All subjects will be asked to fast and avoid caffeine for 12 hours prior to study visit. Demographic and clinical data will be collected by study coordinators. After a focused exam, conducted by a hepatologist to determine health status of the participants, the PI and a research nurse will interview participants to assess their symptoms and AD (Aim 1). Blood (20 ml) samples will be collected via venipuncture for serum and plasma inflammatory markers and IR (Aim 2).

Aim 2. Examine the impact of systemic inflammation (SI) and insulin resistance (IR) as mediators of manifestations of AD and symptoms experienced by NAFLD patients. Increased presence of adipocytes may produce high, chronic levels of cytokines such as IL-6 and TNF-α resulting in higher levels of APRPs which contribute to overall inflammation as well as cognitive decline and fatigue. Secondly, elevated levels of IL-6 and TNF-α lower levels of CTRPs which exacerbate IR, AD, and muscle and cardiac problems reported in NAFLD. Through the use of plasma analysis, levels of cytokines such as IL-6, TNF-α, and APRPs can be performed in a high throughput BioPlex® assay (Bio-Rad Laboratories, Inc.: Hercules, CA). We have extensive experience with these types of assays and have generated data using human samples in numerous studies conducted through the Center of Excellence for Biobehavioral Approaches to Symptom Management (CEBASM) at the School of Nursing. CTRP family members are also expressed in the plasma and at detectible levels. We will perform ELISA analysis to compare circulating levels of the various CTRPs using commercially available CTRP ELISA kits/reagents. Insulin resistance (IR) will be assessed by HOMO-IR utilizing fasting glucose and insulin.


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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Impact of Autonomic Dysfunction on Liver-Related Symptoms in Non-Alcoholic Fatty Liver Disease and Their Relationship to Systemic Inflammation and Insulin Resistance
Study Start Date : May 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016





Primary Outcome Measures :
  1. Autonomic Dysfunction [ Time Frame: baseline ]
    Will record heart rate variability at the time of study visit and collect data from 24 hour automatic blood pressure readings. The Autonomic Symptoms Checklist will also be used.


Secondary Outcome Measures :
  1. Relationship between AD and symptoms [ Time Frame: baseline ]
    Data on symptoms will be collected using the Chronic Liver Disease Questionnaire and PROMIS symptom short forms for symptoms including fatigue, anxiety, sleep and depression. RBANS and Stroop will be used to assess cognitive function.



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with NAFLD who are patients at the NAFLD Clinic at VCU Health Systems in Richmond, VA.
Criteria

Inclusion Criteria:

  • Men and women within the age of 35-65
  • understand and speak English
  • NAFLD on liver histology by the biopsy within preceding 24 months

Exclusion Criteria:

  • Patients with poorly controlled diabetes (HbA1c>8.5% or fasting blood glucose>150 mg/dl)
  • renal dysfunction (Cr>1.5) last 3 months
  • history of cardiac rhythm other than sinus rhythm
  • on beta-blockers
  • other liver diseases (HCV, HBV)
  • decompensated cirrhosis (free of ascites hepatic encephalopathy, variceal bleeding)
  • major depression
  • cancer
  • stroke
  • any other major health conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132780


Locations
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United States, Virginia
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Kyungeh An, PhD VCU

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02132780     History of Changes
Other Study ID Numbers: HM20000329
UL1TR000058 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We completed this pilot with 23 participants. Sharing data is to be determined.

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Autonomic Nervous System Diseases
Primary Dysautonomias
Digestive System Diseases
Nervous System Diseases