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

Completed

Conditions studied: Fatty Liver

In brief

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.

Key facts

Study ID

NCT02363309

Run by

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

People needed

74

Starts

2015-03-27

Expected to finish

2018-11-29

Last updated by the study team

2021-08-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Presence of definite or probable drug-induced liver injury. In the case of lipid-lowering, anti-hypertensive or anti-diabetic medications that are suspected to cause elevation of aminotransferases, patients will be eligible if treatment is associated with stable enzyme levels for at least 6 months and inclusion criteria 2a. and 2c. are both present.
• 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

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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