Fatty LiverEarly Phase 1LiverNCT00949403
Liver Positron Emission Tomography (PET) Study of Non Alcoholic Fatty Liver Disease
A Early Phase 1 study testing Radio pharmaceuticals C-11 Acetate, and C-11 Palmitate in people with Fatty Liver, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate how the liver receives and uses fats for energy. This will help the investigators further understand the physical and chemical processes responsible for Non-Alcoholic Fatty Liver Disease (NAFLD) in overweight females with or without NAFLD who are scheduled to undergo gastric… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fatty Liver
- What is being tested?
- Radio pharmaceuticals C-11 Acetate, and C-11 Palmitate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to 19 Jan 2011
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Obese females with a BMI of greater then or equal to 45.
- Age range between 18-45 years.
- Patients undergoing bariatric surgery at Barnes-Jewish Hospital-St.Louis,MO.
Who cannot join
- Any prior history or evidence of liver disease other than Non-Alcoholic Fatty liver Disease, severe hypertriglyceridemia and diabetes mellitis.
- Consumed greater then or equal to 20 grams of alcohol per day.
- Taking medications that are known to cause hepatic steatosis \& liver damage.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Washington University School of Medicine
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
About this study
Official title: An Interdisciplinary Approach to the Study of Non-alcoholic Fatty Liver Disease
The purpose of this study is to evaluate how the liver receives and uses fats for energy. This will help the investigators further understand the physical and chemical processes responsible for Non-Alcoholic Fatty Liver Disease (NAFLD) in overweight females with or without NAFLD who are scheduled to undergo gastric bypass surgery.
Read the detailed description
This study involves a multidisciplinary approach that will address the metabolic mechanisms responsible for Non-alcoholic Fatty Liver Disease (NAFLD) in humans. Nonalcoholic fatty liver disease (NAFLD) has become an important public health problem in many industrialized countries because of its high prevalence, potential progression to severe liver disease, and association with cardiometabolic abnormalities, including diabetes, the metabolic syndrome, dilated cardiomyopathy, and coronary heart disease. Although obesity is an important risk factor for NAFLD many obese persons have minimal or no steatosis. The mechanism responsible for the pathogenesis of steatosis is not known, but must involve one or more of the following:
- Increased hepatic fatty acid (FA) delivery
- Decreased hepatic FA oxidation
- Increased de novo lipogenesis (DNL)
- Inadequate hepatic triglyceride secretion
We hypothesize that alterations in all of these metabolic processes are involved in the pathogenesis of NAFLD. However, a comprehensive evaluation of these factors in individual cohorts of subjects has never been performed, and the ability to measure hepatic FA oxidation in vivo in human subjects has not been available.
The following Specific Aims will be evaluated in obese women with and without NAFLD, who are scheduled for bariatric surgery:
- Determine hepatic FA uptake and oxidation by using novel PET techniques in combination with measurements of DNL using stable isotope tracers and by assessing liver tissue FA oxidative capacity by evaluating gene expression of FA oxidative enzymes and mitochondrial content.
- Determine hepatic fatty acid delivery by using stable isotope tracers to assess the rate of free FA (FFA) release into plasma and cellular biology methods to determine the expression and protein content of the major tissue FA transporter (CD36).
- Determine hepatic very-low-density lipoprotein TG (VLDL-TG) secretion rate by using stable isotope tracers.
- Determine liver histology and factors involved in inflammation and fibrosis by using routine staining and immunohistochemistry.
- Conditions
- Fatty Liver
- Being tested
- Radio pharmaceuticals C-11 Acetate, and C-11 Palmitate
- Keywords
- Non-Alcoholic Fatty Liver disease
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio pharmaceuticals C-11 Acetate, and C-11 PalmitateDrug
injection of C-11 Palmitate and C-11 Acetate during PET/CT to determine Liver metabolism
| Study group | Role | What they receive |
|---|---|---|
| Obese Females (pre-bariatric surgery) | Experimental | Twenty obese females (18-45 years of age, BMI > or equal to 45) who are scheduled to undergo bariatric surgery at Barnes-Jewish Hospital will be screened for enrollment over 2 years. They will be imaged with PET/CT and radiopharmaceuticals C-11 Acetate and C-11 Palmitate will be injected. Receives: Drug: Radio pharmaceuticals C-11 Acetate, and C-11 Palmitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Fatty Acid Oxidation
Liver fatty acid oxidation as determined by 1-11C-palmitate PET imaging.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completion19 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Robert J Gropler, MD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949403
- Sponsor's protocol ID
- 09-0621
- Acronym
- Liver
- Status last verified
- Jun 2020
- First submitted
- 28 Jul 2009
- Last updated
- 22 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interdisciplinary Approach to the Study of Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT00949403
- Acronym / sponsor ID
- Liver / 09-0621
- Conditions
- Fatty Liver
- Keywords
- Non-Alcoholic Fatty Liver disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- 19 Jan 2011 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Posted 22 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate how the liver receives and uses fats for energy. This will help the investigators further understand the physical and chemical processes responsible for Non-Alcoholic Fatty Liver Disease (NAFLD) in overweight females with or without NAFLD who are scheduled to undergo gastric bypass surgery.
Detailed description
This study involves a multidisciplinary approach that will address the metabolic mechanisms responsible for Non-alcoholic Fatty Liver Disease (NAFLD) in humans. Nonalcoholic fatty liver disease (NAFLD) has become an important public health problem in many industrialized countries because of its high prevalence, potential progression to severe liver disease, and association with cardiometabolic abnormalities, including diabetes, the metabolic syndrome, dilated cardiomyopathy, and coronary heart disease. Although obesity is an important risk factor for NAFLD many obese persons have minimal or no steatosis. The mechanism responsible for the pathogenesis of steatosis is not known, but must involve one or more of the following:
- Increased hepatic fatty acid (FA) delivery
- Decreased hepatic FA oxidation
- Increased de novo lipogenesis (DNL)
- Inadequate hepatic triglyceride secretion
We hypothesize that alterations in all of these metabolic processes are involved in the pathogenesis of NAFLD. However, a comprehensive evaluation of these factors in individual cohorts of subjects has never been performed, and the ability to measure hepatic FA oxidation in vivo in human subjects has not been available.
The following Specific Aims will be evaluated in obese women with and without NAFLD, who are scheduled for bariatric surgery:
- Determine hepatic FA uptake and oxidation by using novel PET techniques in combination with measurements of DNL using stable isotope tracers and by assessing liver tissue FA oxidative capacity by evaluating gene expression of FA oxidative enzymes and mitochondrial content.
- Determine hepatic fatty acid delivery by using stable isotope tracers to assess the rate of free FA (FFA) release into plasma and cellular biology methods to determine the expression and protein content of the major tissue FA transporter (CD36).
- Determine hepatic very-low-density lipoprotein TG (VLDL-TG) secretion rate by using stable isotope tracers.
- Determine liver histology and factors involved in inflammation and fibrosis by using routine staining and immunohistochemistry.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese Females (pre-bariatric surgery) | Experimental | Drug: Radio pharmaceuticals C-11 Acetate, and C-11 PalmitateTwenty obese females (18-45 years of age, BMI > or equal to 45) who are scheduled to undergo bariatric surgery at Barnes-Jewish Hospital will be screened for enrollment over 2 years. They will be imaged with PET/CT and radiopharmaceuticals C-11 Acetate and C-11 Palmitate will be injected. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obese females with a BMI of greater then or equal to 45.
- Age range between 18-45 years.
- Patients undergoing bariatric surgery at Barnes-Jewish Hospital-St.Louis,MO.
Key exclusion criteria (3 listed)
- Any prior history or evidence of liver disease other than Non-Alcoholic Fatty liver Disease, severe hypertriglyceridemia and diabetes mellitis.
- Consumed greater then or equal to 20 grams of alcohol per day.
- Taking medications that are known to cause hepatic steatosis \& liver damage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radio pharmaceuticals C-11 Acetate, and C-11 Palmitateinjection of C-11 Palmitate and C-11 Acetate during PET/CT to determine Liver metabolism | Drug | Obese Females (pre-bariatric surgery) |
Primary outcome
Hepatic Fatty Acid Oxidation
Time frame: 3 hours
Liver fatty acid oxidation as determined by 1-11C-palmitate PET imaging.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers
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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.
Robert J Gropler, MD principal investigator
PI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Radio pharmaceuticals C-11 Acetate, and C-11 Palmitate in people with Fatty Liver, run by Washington University School of Medicine at 2 sites 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 3 inclusion and 3 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 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hepatic Fatty Acid Oxidation (time frame: 3 hours). 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 22 Jun 2020.