Nonalcoholic Fatty LiverNCT03151798
The Liver Health Study for Patients with NAFLD
A study testing Phase II: Lifestyle treatment and Phase I: Observational studies in people with Nonalcoholic Fatty Liver and Nonalcoholic Steatohepatitis, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The study will investigate whether the level of fat stored in the liver is related to the liver's ability to burn fat. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Obesity
- What is being tested?
- Phase II: Lifestyle treatment and Phase I: Observational studies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2017to 29 Apr 2023
- Phase
- Interventional
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women (pre and post-menopausal)
- Overweight/obese with BMI ≥ 25.9 or < 50.0 kg/m2
- Characteristics of the metabolic syndrome, pre-diabetes (fasting glucose 100-125 mg/dL or 2h glucose 140-200 mg/dL) or diabetes type 2, or undergoing bariatric surgery
- 22-65 years of age
- Sedentary, < 60 minutes per week of structured physical activity
- Alcohol intake< 20 g/d
Who cannot join
- Having undergone bariatric surgery.
- Acute disease or advanced cardiac or renal disease, anticoagulation therapy, or any severe co-morbid condition limiting life expectancy < 1 years
- Other causes of hepatitis including hepatitis B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis, any clinical or biochemical evidence of decompensated liver disease
- Use of steroids or other drugs that cause NAFLD
- Pregnant or trying to become pregnant
- Inability to exercise on a bike or treadmill
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrient Overload, Insulin Resistance, and Hepatic Mitochondrial Dysfunction
The study will investigate whether the level of fat stored in the liver is related to the liver's ability to burn fat.
Read the detailed description
The study has two phases. In Phase I, liver samples from patients undergoing bariatric surgery or a diagnostic liver biopsy will be tested for the ability to burn fatty acids. In Phase II, patients with nonalcoholic fatty liver disease will participate in either a nine-month lifestyle treatment program or undergo standard care. The goal is to determine how weight loss and exercise improve liver health.
Inpatient comprehensive metabolic tests are performed before and after the nine-months.
- Being tested
- Phase II: Lifestyle treatment, Phase II: Control treatment, Phase I: Observational studies
- Keywords
- Nonalcoholic fatty liver, Exercise, Weight loss diet
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase II: Lifestyle treatmentBehavioural
Subjects will undergo energy restriction and exercise training over a 9 month period.
Phase II: Control treatmentBehavioural
Subjects will receive dietary advice and receive information on a stretching program.
Phase I: Observational studiesOther
The liver samples from patients undergoing bariatric surgery or a diagnostic liver biopsy will undergo in vitro assays to determine the capacity of the tissue to burn fat
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Observational studies | Experimental | Patients are eligible who are undergoing either bariatric surgery or a liver biopsy for the diagnosis of nonalcoholic fatty liver disease Receives: Other: Phase I: Observational studies |
| Phase II: Lifestyle treatment | Experimental | Subjects will undergo lifestyle modification to cause weight loss and improved fitness Receives: Behavioral: Phase II: Lifestyle treatment |
| Phase II: Control treatment | Placebo comparator | Subjects will be given dietary advice and a stretching program. Receives: Behavioral: Phase II: Control treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver mitochondrial gene expression
Liver tissue will be tested in vitro to determine the abundance of transcript indicative of fat oxidation.
Measured: 1 day
Secondary outcomes (2)
Liver mitochondrial fat oxidation
Liver tissue will be tested in vitro to determine its capacity to burn fat
Measured: 1 day
Histology to determine the amount of fibrosis in the liver
Liver samples will be tested to determine the severity of liver disease and whether diet and exercise reduce liver fibrosis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start9 Aug 2017
- Primary completion3 Mar 2022
- Study completion29 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty LiverStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- In Phase I, liver samples derived from patients undergoing either bariatric surgery or a liver biopsy to diagnose nonalcoholic fatty liver disease, are tested one time in vitro. There is no treatment in Phase I. In Phase II, only patients with nonalcoholic fatty liver disease (and not those who have had bariatric surgery) are eligible to go into a study in which they are randomly assigned to 1) a lifestyle treatment program or 2) a control group undergoing standard care. Allocation is 2:1 subjects in the treatment vs standard care groups. Thus, the arms are: Arm 1: Phase I studies with no treatment, only observational data generated in vitro from the liver samples Arm 2: Phase II lifestyle treatment Arm 3: Phase II control standard of care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Jane Parks, University of Missouri-Columbia
- Investigators
- Elizabeth Parks, PhD, Principal investigator, University of Missouri-ColumbiaJamal Ibdah, MD, Principal investigator, University of Missouri-ColumbiaScott Rector, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151798
- Sponsor's protocol ID
- 2008258
- Status last verified
- Jul 2023
- First submitted
- 10 May 2017
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Syed-Abdul MM, Moore MP, Wheeler A, Ganga RR, Diaz-Arias A, Rector RS, Ibdah JA, Parks EJ. Improvements in nonalcoholic fatty liver disease (NAFLD) after metabolic surgery is linked to an increased hepatic fatty acid oxidation-a case report. AME Surg J. 2021 Jun 30;1:4. doi: 10.21037/asj-20-5.
PubMed 40255245Mucinski JM, Salvador AF, Moore MP, Fordham TM, Anderson JM, Shryack G, Cunningham RP, Lastra G, Gaballah AH, Diaz-Arias A, Ibdah JA, Rector RS, Parks EJ. Histological improvements following energy restriction and exercise: The role of insulin resistance in resolution of MASH. J Hepatol. 2024 Nov;81(5):781-793. doi: 10.1016/j.jhep.2024.06.017. Epub 2024 Jun 22.
PubMed 38914313
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrient Overload, Insulin Resistance, and Hepatic Mitochondrial Dysfunction
- ClinicalTrials.gov ID
- NCT03151798
- Acronym / sponsor ID
- 2008258
- Keywords
- Nonalcoholic fatty liver, Exercise, Weight loss diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 29 Apr 2023 (actual)
- First posted
- 12 May 2017 (actual)
- 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.
The study will investigate whether the level of fat stored in the liver is related to the liver's ability to burn fat.
Detailed description
The study has two phases. In Phase I, liver samples from patients undergoing bariatric surgery or a diagnostic liver biopsy will be tested for the ability to burn fatty acids. In Phase II, patients with nonalcoholic fatty liver disease will participate in either a nine-month lifestyle treatment program or undergo standard care. The goal is to determine how weight loss and exercise improve liver health.
Inpatient comprehensive metabolic tests are performed before and after the nine-months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- In Phase I, liver samples derived from patients undergoing either bariatric surgery or a liver biopsy to diagnose nonalcoholic fatty liver disease, are tested one time in vitro. There is no treatment in Phase I. In Phase II, only patients with nonalcoholic fatty liver disease (and not those who have had bariatric surgery) are eligible to go into a study in which they are randomly assigned to 1) a lifestyle treatment program or 2) a control group undergoing standard care. Allocation is 2:1 subjects in the treatment vs standard care groups. Thus, the arms are: Arm 1: Phase I studies with no treatment, only observational data generated in vitro from the liver samples Arm 2: Phase II lifestyle treatment Arm 3: Phase II control standard of care
| Arm | Type | Receives |
|---|---|---|
| Phase I: Observational studies | Experimental | Other: Phase I: Observational studiesPatients are eligible who are undergoing either bariatric surgery or a liver biopsy for the diagnosis of nonalcoholic fatty liver disease |
| Phase II: Lifestyle treatment | Experimental | Behavioral: Phase II: Lifestyle treatmentSubjects will undergo lifestyle modification to cause weight loss and improved fitness |
| Phase II: Control treatment | Placebo comparator | Behavioral: Phase II: Control treatmentSubjects will be given dietary advice and a stretching program. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women (pre and post-menopausal)
- Overweight/obese with BMI ≥ 25.9 or < 50.0 kg/m2
- Characteristics of the metabolic syndrome, pre-diabetes (fasting glucose 100-125 mg/dL or 2h glucose 140-200 mg/dL) or diabetes type 2, or undergoing bariatric surgery
- 22-65 years of age
- Sedentary, < 60 minutes per week of structured physical activity
Key exclusion criteria (6 listed)
- Having undergone bariatric surgery.
- Acute disease or advanced cardiac or renal disease, anticoagulation therapy, or any severe co-morbid condition limiting life expectancy < 1 years
- Other causes of hepatitis including hepatitis B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis, any clinical or biochemical evidence of decompensated liver disease
- Use of steroids or other drugs that cause NAFLD
- Pregnant or trying to become pregnant
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 |
|---|---|---|
| Phase II: Lifestyle treatmentSubjects will undergo energy restriction and exercise training over a 9 month period. | Behavioural | Phase II: Lifestyle treatment |
| Phase II: Control treatmentSubjects will receive dietary advice and receive information on a stretching program. | Behavioural | Phase II: Control treatment |
| Phase I: Observational studiesThe liver samples from patients undergoing bariatric surgery or a diagnostic liver biopsy will undergo in vitro assays to determine the capacity of the tissue to burn fat | Other | Phase I: Observational studies |
Primary outcome
Liver mitochondrial gene expression
Time frame: 1 day
Liver tissue will be tested in vitro to determine the abundance of transcript indicative of fat oxidation.
2 secondary outcomes
Liver mitochondrial fat oxidation
Time frame: 1 day
Histology to determine the amount of fibrosis in the liver
Time frame: 1 day
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 19 Dec 2024.
- Derived from this study: PubMed 40255245Syed-Abdul MM, Moore MP, Wheeler A, Ganga RR, Diaz-Arias A, Rector RS, Ibdah JA, Parks EJ. Improvements in nonalcoholic fatty liver disease (NAFLD) after metabolic surgery is linked to an increased hepatic fatty acid oxidation-a case report. AME Surg J. 2021 Jun 30;1:4. doi: 10.21037/asj-20-5.
- Derived from this study: PubMed 38914313Mucinski JM, Salvador AF, Moore MP, Fordham TM, Anderson JM, Shryack G, Cunningham RP, Lastra G, Gaballah AH, Diaz-Arias A, Ibdah JA, Rector RS, Parks EJ. Histological improvements following energy restriction and exercise: The role of insulin resistance in resolution of MASH. J Hepatol. 2024 Nov;81(5):781-793. doi: 10.1016/j.jhep.2024.06.017. Epub 2024 Jun 22.
- Individual participant dataSharing planned: No
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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.
Elizabeth Parks, PhD principal investigator
University of Missouri-Columbia
Jamal Ibdah, MD principal investigator
University of Missouri-Columbia
Scott Rector, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase II: Lifestyle treatment and Phase I: Observational studies in people with Nonalcoholic Fatty Liver and Nonalcoholic Steatohepatitis, run by University of Missouri-Columbia 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 6 inclusion and 6 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 19 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
Liver mitochondrial gene expression (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151798, which also lists 2 linked publications.
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 19 Dec 2024.