Palmitate Breath Test to Assess Fatty Acid Oxidation in Non Alcoholic Fatty Liver Disease (NAFLD)

NCT02363309 | Completed

• 2 other identifiers: 15008015-DK-0080
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Non-alcoholic fatty liver disease (NAFLD) is a common cause of abnormal liver tests. It is closely linked to health problems like obesity and diabetes. Researchers want to use a breath test to measure the metabolism of fatty acids and learn more about the causes of disease. They will compare the results between people who do and do not have NAFLD. They will also repeat the test in people with NAFLD after treatment to see improvement. Objectives: \- To measure the metabolism of fatty acids and compare them between people who do and do not have NAFLD, and people with NAFLD before and after treatment. Eligibility:

• People age 21 and older with NAFLD
• Healthy volunteers
• non-NAFLD metabolic syndrome Design:
• Participants will be screened with medical history, physical exam, and fasting blood tests.
• Participants will fast overnight.
• Participants will sit in a comfortable chair. They will relax for 15 minutes. Then a narrow plastic tube will be put under their nostrils. It will be connected to a breath test device.
• Participants will drink palmitate or acetate in a heated liquid meal (Ensure). Palmitate is a fatty acid and acetate is a small molecule that is a building block for fatty acids. Both palmitate and acetate are natural compounds that are in our body and our food.
• Participants will sit for 6 hours. They can read, watch television, work on a computer, or other relaxed activity. The air they breathe out from their nose will be collected and analyzed. They may take a bathroom break after 3 hours. They may drink water after 3 hours.
• Participants will get a meal after the test.
• Participants will have another visit at least 1 week later. They will repeat the test with the other compound (acetate of palmitate).
• Participants may be asked to repeat a test to study the result of a change like weight loss or medicine. Thus, participation can last from 1 week to several years.

Conditions

Fatty Liver

Keywords

13C; Fatty Liver; Acetate; Breath Tests; Palmitate

Outcome Measures

Primary Outcomes (1)

• Measure rates of fatty acid oxidation in patients with non alcoholic fatty liver disease

  Differences in rates of fatty acid oxidation in patients with non alcoholic fatty liver disease.

  End of study

Study Arms (3)

Healthy Volunteers

Subjects without liver disease or metabolic syndrome

NAFLD subjects

Subjects with Non-Alcoholic Fatty Liver Disease

non-NAFLD metabolic syndrome

Subjects who have metabolic syndrome but do not have Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary clinical and community sample

You may qualify if:

• Age above 21 years, male or female.
• Estimated average alcohol consumption \< 30 g/d for men or \< 20 g/d for women in the 6 months prior to enrollment and no binge-drinking behavior.
• Clinical suspicion of NAFLD, defined by a liver biopsy result consistent with NAFLD 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 enrollment.
• 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 criteria30 as the presence of at least three of:
• Abdominal obesity, defined as waist circumference \> 102 cm for men or \> 88 cm for women
• Elevated triglycerides (\> 150 mg/dL) or the use of medication to lower triglycerides
• Reduced HDL cholesterol (\< 40 mg/DL for men or \< 50 mg/dL for women)
• Elevated blood pressure (\> 135/80 mmHg) or use of medication for hypertension
• Elevated fasting glucose levels (\> 100 mg/dL) or use of antidiabetic medication
• Enrolled in 13-DK-0002
• Non-alcoholic liver disease subjects treated off-protocol with lifestyle intervention or vitamin E treatment.
• Evidence of metabolic syndrome as defined in NAFLD criterion 1.c.
• Normal transaminases (ALT less than or equal to 31 U/L for men or less than or equal to19 U/L for women, or AST less than or equal to 30 U/L) at screening

You may not qualify if:

• Disorders leading to CO2 retention or significant respiratory abnormalities such as severe congestive heart failure, severe pulmonary hypertension or severe chronic obstructive lung disease.
• Disorders interfering with substrate absorption such as gastric bypass surgery, malabsorption disorders, use of orlistat or bile acid sequestrants, or extensive small bowel resection.
• Pregnancy or lactation
• Inability to remain seated for the duration of the test.
• Inability to understand and give informed consent
• 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 who are inactive carriers of HBV (HBV DNA \< 1000 copies/mL, HBeAg negative, Anti HDV negative) for at least 12 months prior to enrollment are also eligible. Patients receiving antiviral therapy are ineligible.
• Concomitant liver disease such as autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency.
• Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen
• Diabetic patients requiring insulin treatment
• Milk or soy protein allergy
• Uncontrolled hypo/hyperthyroidism

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; 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: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 16, 2015
• Study Start: March 27, 2015
• Primary Completion: June 28, 2018
• Study Completion: November 29, 2018
• Last Updated: August 13, 2021

Record last verified: 2021-08

Locations

US (1)