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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatic Steatosis
- Sponsor
- Boston Children's Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- percent liver fat as determined by nMR spectroscopy
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
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
- •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
Outcomes
Primary Outcomes
percent liver fat as determined by nMR spectroscopy
Time Frame: 6 months
Secondary Outcomes
- hepatic steatosis as measured by T1 weighted MRI images(6 monhts)
- visceral fat(6 months)
- liver function tests(6 months)
- measures of oxidative stress(6 months)
- measures of chronic inflammation(6 months)
- insulin resistance(6 months)
- serum lipids(6 months)
- blood pressure(6 months)
- insulin secretion(baseline)
- measures of glucose tolerance(6 months)
- adiponectin(6 months)