Clinical trial NCT00480922: Effects of a Low Glycemic Load Diet on Fatty Liver in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Steatosis
Keywords: non-alcoholic fatty liver disease
steatohepatitis
overweight
insulin resistance
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2007-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: percent liver fat as determined by nMR spectroscopy
timeFrame: 6 months
Secondary outcomes:
measure: hepatic steatosis as measured by T1 weighted MRI images
timeFrame: 6 monhts
measure: visceral fat
timeFrame: 6 months
measure: liver function tests
timeFrame: 6 months
measure: measures of oxidative stress
timeFrame: 6 months
measure: measures of chronic inflammation
timeFrame: 6 months
measure: insulin resistance
timeFrame: 6 months
measure: serum lipids
timeFrame: 6 months
measure: blood pressure
timeFrame: 6 months
measure: insulin secretion
timeFrame: baseline
measure: measures of glucose tolerance
timeFrame: 6 months
measure: adiponectin
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: David S Ludwig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ramon-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.