Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease

NCT02520609 | Completed

• 2 other identifiers: 15017415-DK-0174
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatty Liver; Liver Disease

Keywords

Metabolomics; Non-Alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease; Energy Expenditure; Natural History

Outcome Measures

Primary Outcomes (1)

• Metabolomics readout

  Plasma metabolomic Readout

  One point measure

Study Arms (3)

Healthy volunteers

Healthy volunteers

Patients with metabolic syndrome without NAFLD

Patients with metabolic syndrome without NAFLD

Patients with NAFLD

Patients with NAFLD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• For the entire cohort:
• Male or female aged \> 18 years
• Ability to provide informed consent
• For group 1 subjects (NAFLD)
• Biopsy-proven NAFLD within 2 years prior to screening, OR
• The presence of at least two of the following criteria:
• Suggestion of liver fat by an imaging study (ultrasound, CT scan, MRI or MR spectroscopy) performed in the 6 months prior to screening
• Elevated aminotransferase levels (ALT \> 31 U/L for men or \> 19 U/L for women, or AST \> 30 U/L) on at least two occasions in the 6 months preceding enrollment.
• Presence of the metabolic syndrome, defined according to the modified AHA/NCEP criteria as the presence of at least three of:
• i. Abdominal obesity, defined as waist circumference \> 102 cm for men or \> 88 cm for women
• ii. Elevated triglycerides (\> 150 mg/dL) or the use of medication to lower triglycerides
• iii. Reduced HDL cholesterol (\< 40 mg/DL for men or \< 50 mg/dL for women)
• iv. Elevated blood pressure (\> 135/80 mmHg) or use of medication for hypertension
• v. Elevated fasting glucose levels (\> 100 mg/dL) or use of anti-diabetic medication
• For group 2 subjects (non-NAFLD metabolic syndrome):

You may not qualify if:

• 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).
• Pregnancy or lactation
• 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.
• Diabetic patients requiring insulin treatment
• Lactose intolerance or allergy to Ensure or one or more of its components
• Hyper/hypothyroidism
• Inability to remain sedentary for 4 hours, or to remain for 26-30 hours in the metabolic chamber
• Inability to obtain vascular access for the required blood samples

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Yaron Rotman, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2015
• First Posted: August 13, 2015
• Study Start: October 28, 2015
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: April 24, 2026

Record last verified: 2025-07-03

Locations

US (1)