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NCT02363309 · ClinicalTrials.gov registry record
Palmitate Breath Test to Assess Fatty Acid Oxidation in Non Alcoholic Fatty Liver Disease (NAFLD)
A clinical trial of Fatty Liver, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 74
- Enrollment target
- 1
- Study location
NCT02363309: Completed study of Fatty Liver, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02363309 is a study of Fatty Liver that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 74 participants, below the 207-participant average among 20 other Fatty Liver trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02363309, a study of Fatty Liver, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 74 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Differences in rates of fatty acid oxidation in patients with non alcoholic fatty liver disease.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2015-03-27 |
| Est. Completion | 2018-11-29 |
What the finished NCT02363309 record still lists
NCT02363309 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 207-participant average among 20 other Fatty Liver trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Fatty Liver appearing as the primary indexed condition, and to 0 interventions.
NCT02363309 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02363309 about?
NCT02363309 is a clinical study titled "Palmitate Breath Test to Assess Fatty Acid Oxidation in Non Alcoholic Fatty Liver Disease (NAFLD)". 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...
What is the current status of trial NCT02363309?
This trial is currently completed. The enrollment target is 74 participants. The study started on 2015-03-27. Estimated completion is 2018-11-29.
What conditions does trial NCT02363309 study?
This clinical trial studies the following conditions: Fatty Liver.
Who is sponsoring clinical trial NCT02363309?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02363309 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02363309's enrollment target sits among peer trials
74 8th of 20 higher than 13 of 20 other Fatty Liver trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fatty Liver trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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