Fatty LiverNCT00585299
Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD
A study testing Low-fat diet and Traditional diet in people with Fatty Liver and Insulin Resistance, run by Yale University at 1 site in United States.
Trial summary
To assess whether reversal of fatty liver by moderate weight loss (8% of body weight) will lead to improvements in insulin sensitivity, which will be associated with changes in both glucose status and lipid profiles, in obese children and adolescents with fatty liver who have normal glucose or pre-diabetes. Read more about this study
- Who is it for?
- Ages 10 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatty Liver, Insulin Resistance
- What is being tested?
- Low-fat diet and Traditional diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2010
- 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 10 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 10 to 21 yrs of age
- Non-smoking
- BMI >95th percentile for age and gender, but BMI <40
- Suspicion of fatty liver, with a high ALT (>35)
- Normal glucose tolerance or prediabetes (impaired glucose tolerance or impaired fasting glucose)
Who cannot join
- Females of child-bearing potential who are not using birth control
- Pregnant or lactating females
- Current medications except oral anti-diabetic medications and hormonal birth control
- Lipid-lowering medication that increases liver enzymes
- Significant kidney dysfunction (creatinine >1.5 mg/dL)
- Current heavy ethanol use or recent history of binge drinking
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- History or evidence of hepatitis A, B, or C, Wilson's Disease, or alpha-1-antitrypsin deficiency
- Known to be HIV positive
- Symptomatic angina pectoris or cardiac insufficiency as defined by the NYHA classification as Functional Class III or IV
- Major vascular event within 6 months of screening (e.g. MI, stroke)
- Active cancer within 5 years prior to screening
- Current systemic disease, including type 1 or 2 diabetes
- Enrolled in another research study within 1 month prior to screening
- Implanted paramagnetic material (all subjects will need to fill out the Yale Magnetic Resonance Center safety checklist)
- Anemia (HCT <35%)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
To assess whether reversal of fatty liver by moderate weight loss (8% of body weight) will lead to improvements in insulin sensitivity, which will be associated with changes in both glucose status and lipid profiles, in obese children and adolescents with fatty liver who have normal glucose or pre-diabetes.
Read the detailed description
This study will have two groups: one group that eats a moderate calorie, low-fat diet and is weighed regularly (every other week for 16 weeks) and the other who receives traditional diet therapy and returns in 16 weeks. Both groups will undergo procedures that test glucose tolerance and measure liver and muscle fat content before and after study period.
- Conditions
- Fatty Liver, Insulin Resistance
- Being tested
- Low-fat diet, Traditional diet
- Keywords
- steatosis, fatty liver, insulin sensitivity, fatty liver (steatosis)
- Medical subject headings
- Fatty Liver, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat dietOther
20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks
Traditional dietOther
Traditional low-fat diet with dietitian follow-up in 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low-fat diet | Experimental | 20% kcals from fat diet followed for 8 weeks then 8 weeks of maintenance diet with visits to dietitian every other week Receives: Other: Low-fat diet; Other: Traditional diet |
| Traditional | Active comparator | Traditional low-fat diet given and dietitian follows up in 16 weeks Receives: Other: Traditional diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Enzyme, liver and muscle fat content, glucose tolerance status
Measured: 16-18 weeks
Secondary outcomes (1)
plasma lipid levels
Measured: 16-18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startOct 2006
- Primary completionJun 2010
- Study completionSep 2010
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 Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Sonia Caprio, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585299
- Sponsor's protocol ID
- 0212023115
- Other IDs
- R01HD040787-01
- Status last verified
- Jun 2014
- First submitted
- 22 Dec 2007
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD
- ClinicalTrials.gov ID
- NCT00585299
- Acronym / sponsor ID
- 0212023115
- Conditions
- Fatty Liver, Insulin Resistance
- Keywords
- steatosis, fatty liver, insulin sensitivity, fatty liver (steatosis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 3 Jan 2008 (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.
To assess whether reversal of fatty liver by moderate weight loss (8% of body weight) will lead to improvements in insulin sensitivity, which will be associated with changes in both glucose status and lipid profiles, in obese children and adolescents with fatty liver who have normal glucose or pre-diabetes.
Detailed description
This study will have two groups: one group that eats a moderate calorie, low-fat diet and is weighed regularly (every other week for 16 weeks) and the other who receives traditional diet therapy and returns in 16 weeks. Both groups will undergo procedures that test glucose tolerance and measure liver and muscle fat content before and after study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-fat diet | Experimental | Other: Low-fat diet, Other: Traditional diet20% kcals from fat diet followed for 8 weeks then 8 weeks of maintenance diet with visits to dietitian every other week |
| Traditional | Active comparator | Other: Traditional dietTraditional low-fat diet given and dietitian follows up in 16 weeks |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 10 to 21 yrs of age
- Non-smoking
- BMI >95th percentile for age and gender, but BMI <40
- Suspicion of fatty liver, with a high ALT (>35)
- Normal glucose tolerance or prediabetes (impaired glucose tolerance or impaired fasting glucose)
Key exclusion criteria (15 listed)
- Females of child-bearing potential who are not using birth control
- Pregnant or lactating females
- Current medications except oral anti-diabetic medications and hormonal birth control
- Lipid-lowering medication that increases liver enzymes
- Significant kidney dysfunction (creatinine >1.5 mg/dL)
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 |
|---|---|---|
| Low-fat diet20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks | Other | Low-fat diet |
| Traditional dietTraditional low-fat diet with dietitian follow-up in 16 weeks | Other | Low-fat diet, Traditional |
Primary outcome
Liver Enzyme, liver and muscle fat content, glucose tolerance status
Time frame: 16-18 weeks
1 secondary outcome
plasma lipid levels
Time frame: 16-18 weeks
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 17 Jun 2014.
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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.
Sonia Caprio, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-fat diet and Traditional diet in people with Fatty Liver and Insulin Resistance, run by Yale University 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 5 inclusion and 15 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 17 Jun 2014. 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?
Liver Enzyme, liver and muscle fat content, glucose tolerance status (time frame: 16-18 weeks). 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 17 Jun 2014.