Hepatic SteatosisDELIVERNCT00480922
Effects of a Low Glycemic Load Diet on Fatty Liver in Children
A study testing Low glycemic load diet and Low fat diet in people with Hepatic Steatosis, run by Boston Children's Hospital at 1 site in United States.
Trial summary
There has been a recent increase in incidence of obesity and its associated morbidities, including T2 DM, hypertension and hepatic steatosis. Hepatic steatosis is a precursor to non-alcoholic steatohepatitis, cirrhosis and end-stage liver disease. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Hepatic Steatosis
- What is being tested?
- Low glycemic load diet and Low fat diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2009
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI >95th percentile for age and sex
- Weight <300 pounds
- Ability to lie quietly in the MRI for approximately 45 minutes
- Willing and able to attend all sessions.
- Working telephone
- Greater than or equal to 10% hepatic steatosis on nMR spectroscopy
Who cannot join
- Any other medical condition besides obesity that may predispose to liver disease
- Medications that affect liver metabolism
- Any causes of chronic hepatitis
- Diabetes
- Inability to adhere to prescribed diets
- Currently on high-dose vitamins and not willing to discontinue
Show all 9Show fewer
- Weight loss/gain in the past 6 months of >10% of total body weight.
- Sibling of any subject who is already enrolled
- Any alcohol consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing the Effects of a Low Glycemic Load Diet With a Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescents
There has been a recent increase in incidence of obesity and its associated morbidities, including T2 DM, hypertension and hepatic steatosis. Hepatic steatosis is a precursor to non-alcoholic steatohepatitis, cirrhosis and end-stage liver disease. The 1st reported case of pediatric hepatic steatosis was in 1980 and it is now affects 30-77% of overweight children. In addition to its association with obesity, hepatic steatosis has been associated with the metabolic syndrome, insulin resistance, and post-prandial hyperglycemia. Current treatment of hepatic steatosis includes weight loss with a hypocaloric low fat diet. Given the association with insulin resistance and post-prandial hyperglycemia, adult patients with hepatic steatosis that does not respond to weight loss are placed on insulin sensitizing drugs. We hypothesize that weight loss with a diet designed to decrease insulin resistance and post-prandial hyperglycemia, a low glycemic load diet, will provide a safe and effective way to decrease hepatic fat content in the pediatric population. This hypothesis will be tested with a randomized control trial comparing the effect of a low fat diet with a low glycemic load diet.
- Conditions
- Hepatic Steatosis
- Being tested
- Low glycemic load diet, Low fat diet
- Keywords
- non-alcoholic fatty liver disease, steatohepatitis, overweight, insulin resistance
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease, Overweight, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic load dietBehavioural
Outpatient behavioral counseling
Low fat dietBehavioural
Outpatient behavioral counseling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | A low glycemic load diet Receives: Behavioral: Low glycemic load diet |
| 2 | Active comparator | Low fat diet Receives: Behavioral: Low fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent liver fat as determined by nMR spectroscopy
Measured: 6 months
Secondary outcomes (11)
hepatic steatosis as measured by T1 weighted MRI images
Measured: 6 monhts
visceral fat
Measured: 6 months
liver function tests
Measured: 6 months
measures of oxidative stress
Measured: 6 months
measures of chronic inflammation
Measured: 6 months
insulin resistance
Measured: 6 months
serum lipids
Measured: 6 months
blood pressure
Measured: 6 months
insulin secretion
Measured: baseline
measures of glucose tolerance
Measured: 6 months
adiponectin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2009
- Study completionDec 2009
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 Hepatic SteatosisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David S Ludwig, MD, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480922
- Sponsor's protocol ID
- 07-03-0092 (completed)
- Acronym
- DELIVER
- Status last verified
- Aug 2011
- First submitted
- 23 May 2007
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Scribner KB, Pawlak DB, Ludwig DS. Hepatic steatosis and increased adiposity in mice consuming rapidly vs. slowly absorbed carbohydrate. Obesity (Silver Spring). 2007 Sep;15(9):2190-9. doi: 10.1038/oby.2007.260.
PubMed 17890486Ramon-Krauel M, Salsberg SL, Ebbeling CB, Voss SD, Mulkern RV, Apura MM, Cooke EA, Sarao K, Jonas MM, Ludwig DS. A low-glycemic-load versus low-fat diet in the treatment of fatty liver in obese children. Child Obes. 2013 Jun;9(3):252-60. doi: 10.1089/chi.2013.0022. Epub 2013 May 24.
PubMed 23705885
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Effects of a Low Glycemic Load Diet With a Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescents
- ClinicalTrials.gov ID
- NCT00480922
- Acronym / sponsor ID
- DELIVER / 07-03-0092 (completed)
- Conditions
- Hepatic Steatosis
- Keywords
- non-alcoholic fatty liver disease, steatohepatitis, overweight, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 May 2007 (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.
There has been a recent increase in incidence of obesity and its associated morbidities, including T2 DM, hypertension and hepatic steatosis. Hepatic steatosis is a precursor to non-alcoholic steatohepatitis, cirrhosis and end-stage liver disease. The 1st reported case of pediatric hepatic steatosis was in 1980 and it is now affects 30-77% of overweight children. In addition to its association with obesity, hepatic steatosis has been associated with the metabolic syndrome, insulin resistance, and post-prandial hyperglycemia. Current treatment of hepatic steatosis includes weight loss with a hypocaloric low fat diet. Given the association with insulin resistance and post-prandial hyperglycemia, adult patients with hepatic steatosis that does not respond to weight loss are placed on insulin sensitizing drugs. We hypothesize that weight loss with a diet designed to decrease insulin resistance and post-prandial hyperglycemia, a low glycemic load diet, will provide a safe and effective way to decrease hepatic fat content in the pediatric population. This hypothesis will be tested with a randomized control trial comparing the effect of a low fat diet with a low glycemic load diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Low glycemic load dietA low glycemic load diet |
| 2 | Active comparator | Behavioral: Low fat dietLow fat diet |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- BMI >95th percentile for age and sex
- Weight <300 pounds
- Ability to lie quietly in the MRI for approximately 45 minutes
- Willing and able to attend all sessions.
- Working telephone
Key exclusion criteria (9 listed)
- Any other medical condition besides obesity that may predispose to liver disease
- Medications that affect liver metabolism
- Any causes of chronic hepatitis
- Diabetes
- Inability to adhere to prescribed diets
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 glycemic load dietOutpatient behavioral counseling | Behavioural | 1 |
| Low fat dietOutpatient behavioral counseling | Behavioural | 2 |
Primary outcome
percent liver fat as determined by nMR spectroscopy
Time frame: 6 months
11 secondary outcomes
hepatic steatosis as measured by T1 weighted MRI images
Time frame: 6 monhts
visceral fat
Time frame: 6 months
liver function tests
Time frame: 6 months
measures of oxidative stress
Time frame: 6 months
measures of chronic inflammation
Time frame: 6 months
insulin resistance
Time frame: 6 months
serum lipids
Time frame: 6 months
blood pressure
Time frame: 6 months
insulin secretion
Time frame: baseline
measures of glucose tolerance
Time frame: 6 months
adiponectin
Time frame: 6 months
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 26 Aug 2011.
- Background: PubMed 17890486Scribner KB, Pawlak DB, Ludwig DS. Hepatic steatosis and increased adiposity in mice consuming rapidly vs. slowly absorbed carbohydrate. Obesity (Silver Spring). 2007 Sep;15(9):2190-9. doi: 10.1038/oby.2007.260.
- Derived from this study: PubMed 23705885Ramon-Krauel M, Salsberg SL, Ebbeling CB, Voss SD, Mulkern RV, Apura MM, Cooke EA, Sarao K, Jonas MM, Ludwig DS. A low-glycemic-load versus low-fat diet in the treatment of fatty liver in obese children. Child Obes. 2013 Jun;9(3):252-60. doi: 10.1089/chi.2013.0022. Epub 2013 May 24.
Related trials for Hepatic Steatosis
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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
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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.
David S Ludwig, MD, PhD principal investigator
Boston Children's Hospital
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 glycemic load diet and Low fat diet in people with Hepatic Steatosis, run by Boston Children's Hospital 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 9 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 26 Aug 2011. 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?
percent liver fat as determined by nMR spectroscopy (time frame: 6 months). 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 NCT00480922, 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 26 Aug 2011.