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Effects of a Low Glycemic Load Diet on Fatty Liver in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00480922
Acronym
DELIVER
Enrollment
40
Registered
2007-05-31
Start date
2007-05-31
Completion date
2009-12-31
Last updated
2011-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Steatosis

Keywords

non-alcoholic fatty liver disease, steatohepatitis, overweight, insulin resistance

Brief 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. 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.

Interventions

Outpatient behavioral counseling

BEHAVIORALLow fat diet

Outpatient behavioral counseling

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frame
percent liver fat as determined by nMR spectroscopy6 months

Secondary

MeasureTime frame
visceral fat6 months
liver function tests6 months
measures of oxidative stress6 months
measures of chronic inflammation6 months
insulin resistance6 months
hepatic steatosis as measured by T1 weighted MRI images6 monhts
blood pressure6 months
insulin secretionbaseline
measures of glucose tolerance6 months
adiponectin6 months
serum lipids6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026