Fatty LiverNCT02363309
Palmitate Breath Test to Assess Fatty Acid Oxidation in Non Alcoholic Fatty Liver Disease (NAFLD)
An observational study of Fatty Liver, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Fatty Liver
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2015to 29 Nov 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary clinical and community sample
Who may be able to join
- General Inclusion Criteria for all subjects:
- 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.
- Inclusion Criteria for NAFLD:
- 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.
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- 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
- For the purpose of inclusion, the presence of overt diabetes mellitus type 2 will be considered equivalent to the presence of the metabolic syndrome, even if the other criteria are absent.
- For the longitudinal analysis, inclusion criteria:
- Enrolled in 13-DK-0002
- or
- Non-alcoholic liver disease subjects treated off-protocol with lifestyle intervention or vitamin E treatment.
- Inclusion Criteria for non-NAFLD metabolic syndrome:
- 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
- Absence of liver fat by imaging or liver biopsy within 6 months of screening with no (or trace) liver fat
- Inclusion criteria for healthy volunteers
- No history of known liver disease
- Not on any regular systemic medications (with the exception of oral contraceptives)
- BMI less than or equal to 25 kg/m2
- Non diabetic
- Normal ALT and fasting glucose
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Palmitate Breath Test to Assess Fatty Acid Oxidation in Non Alcoholic Fatty Liver Disease
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.
Read more
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.
Read the detailed description
NAFLD is the most common cause for liver enzyme abnormalities in the western world. It is estimated to affect approximately 30% of the US population and is closely associated with the metabolic syndrome and insulin resistance. Dysregulation of fatty acid metabolism and abnormal function of the adipose tissue is thought to be a major feature of insulin resistance and NAFLD. Whether fatty acid oxidation is also dysregulated in patients with NAFLD is unclear. In this study we aim to measure total-body fatty acid oxidation of an oral fat load using the BreathID breath test device and a meal containing 13C-labeled palmitate. Results will be compared between patients with NAFLD, healthy controls and patients with metabolic syndrome but not NAFLD, as well as within NAFLD patients before and after therapeutic interventions.
- Conditions
- Fatty Liver
- Keywords
- 13C, Fatty Liver, Acetate, Breath Tests, Palmitate
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study start27 Mar 2015
- Primary completion28 Jun 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Yaron Rotman, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363309
- Sponsor's protocol ID
- 150080
- Other IDs
- 15-DK-0080
- Status last verified
- Aug 2021
- First submitted
- 13 Feb 2015
- Last updated
- 13 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palmitate Breath Test to Assess Fatty Acid Oxidation in Non Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT02363309
- Acronym / sponsor ID
- 150080
- Conditions
- Fatty Liver
- Keywords
- 13C, Fatty Liver, Acetate, Breath Tests, Palmitate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 27 Mar 2015 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 16 Feb 2015 (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.
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.
Detailed description
NAFLD is the most common cause for liver enzyme abnormalities in the western world. It is estimated to affect approximately 30% of the US population and is closely associated with the metabolic syndrome and insulin resistance. Dysregulation of fatty acid metabolism and abnormal function of the adipose tissue is thought to be a major feature of insulin resistance and NAFLD. Whether fatty acid oxidation is also dysregulated in patients with NAFLD is unclear. In this study we aim to measure total-body fatty acid oxidation of an oral fat load using the BreathID breath test device and a meal containing 13C-labeled palmitate. Results will be compared between patients with NAFLD, healthy controls and patients with metabolic syndrome but not NAFLD, as well as within NAFLD patients before and after therapeutic interventions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary clinical and community sample
Key inclusion criteria (28 listed)
- General Inclusion Criteria for all subjects:
- 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.
- Inclusion Criteria for NAFLD:
- Clinical suspicion of NAFLD, defined by a liver biopsy result consistent with NAFLD or the presence of at least two of the following criteria:
Key exclusion criteria (12 listed)
- 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
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
Measure rates of fatty acid oxidation in patients with non alcoholic fatty liver disease
Time frame: End of study
Differences in rates of fatty acid oxidation in patients with non alcoholic fatty liver disease.
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 13 Aug 2021.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Yaron Rotman, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Fatty Liver, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 28 inclusion and 12 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 13 Aug 2021. 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?
Measure rates of fatty acid oxidation in patients with non alcoholic fatty liver disease (time frame: End of study). 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 13 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.