Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease (NCT02520609) | Clinical Trial Compass
CompletedNot Applicable
Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease
United States53 participantsStarted 2015-10-28
Plain-language summary
Background:
Metabolism refers to the many chemical pathways by which various compounds, including food, are processed and used in the body. People with non-alcoholic fatty liver disease (NAFLD) have too much fat in their liver cells, but what causes it is unclear. One explanation is that people with NAFLD process food and metabolize it differently than people without NAFLD. Researchers want to compare how food is metabolized in people with and without NAFLD.
Objective:
To better understand how food intake influences the development and progression of NAFLD.
Eligibility:
People ages 18 and older with NAFLD or with a non-NAFLD metabolic syndrome
Healthy volunteers ages 18 and older
Design:
Participants will be screened with medical history, surveys, physical exam, and blood tests. This will have ultrasound of the abdomen. This uses sound waves to image internal organs.
Participants will stay at the Clinical Center for 2 nights.
They will fast he first night.
On the second day they will:
Have their metabolism monitored in a metabolism research room for 24 hours
Have a catheter inserted into an arm vein for several blood tests
Drink an Ensure Plus for breakfast
Have solid meals for lunch and dinner
Have several urine tests.
The final morning, they will:
Have more blood tests.
Have a DXA test to measure the fat in the body. They will lie on their backs for 15-25 minutes while an x-ray machine is positioned over areas of the body.
...
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Concomitant liver disease such as autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency
. Chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who were treated successfully for HCV and achieved sustained virological response can be eligible for enrollment \> 18 months after treatment cessation. Patients receiving antiviral therapy are ineligible.
. Estimated average alcohol consumption \> 30 g/d for men or \> 20 g/d for women in the 6 months prior to enrollment, or binge-drinking behavior .
. Gain or loss of \> 10% body weight within the 6 months prior to enrollment.
. Decompensated liver cirrhosis, defined as a past or present occurrence of a decompensation event (variceal bleeding, ascites, spontaneous bacterial peritonitis, encephalopathy or hepatocellular carcinoma or by albumin \< 3 g/dl, PT \> 3 seconds above the upper limit of the norm, platelet count \< 70,000 or total bilirubin \> 2 mg/dL (in the absence of Gilbert s syndrome).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Metabolomics readout
Timeframe: One point measure
Trial details
NCT IDNCT02520609
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
. Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen
. Disorders interfering with substrate absorption such as gastric bypass surgery, malabsorption disorders, use of orlistat or bile acid sequestrants, or extensive small bowel resection.