Non-alcoholic Fatty Liver DiseaseAD-NAFLDNCT02132780
Autonomic Dysfunction in Non-Alcoholic Fatty Liver Disease
An observational study of Non-alcoholic Fatty Liver Disease and NAFLD, run by Virginia Commonwealth University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver, Nonalcoholic
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with NAFLD who are patients at the NAFLD Clinic at VCU Health Systems in Richmond, VA.
Who may be able to join
- Men and women within the age of 35-65
- understand and speak English
- NAFLD on liver histology by the biopsy within preceding 24 months
Who cannot join
- 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)
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- major depression
- cancer
- stroke
- any other major health conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Health System
Richmond, Virginia, 23219
About this study
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
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.
Read the 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.
- Conditions
- Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver, Nonalcoholic, Nonalcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic Dysfunction
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.
Measured: baseline
Secondary outcomes (1)
Relationship between AD and symptoms
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyungeh An, PhD, Principal investigator, VCU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132780
- Sponsor's protocol ID
- HM20000329
- Other IDs
- UL1TR000058
- Acronym
- AD-NAFLD
- Status last verified
- Jun 2017
- First submitted
- 5 May 2014
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: We completed this pilot with 23 participants. Sharing data is to be determined.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02132780
- Acronym / sponsor ID
- AD-NAFLD / HM20000329
- Conditions
- Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver, Nonalcoholic, Nonalcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with NAFLD who are patients at the NAFLD Clinic at VCU Health Systems in Richmond, VA.
Key inclusion criteria (3 listed)
- Men and women within the age of 35-65
- understand and speak English
- NAFLD on liver histology by the biopsy within preceding 24 months
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Relationship between AD and symptoms
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Individual participant dataSharing planned: Undecided. We completed this pilot with 23 participants. Sharing data is to be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyungeh An, PhD principal investigator
VCU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease and NAFLD, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic Dysfunction (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.