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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00480922
Other study ID # 07-03-0092 (completed)
Secondary ID
Status Completed
Phase N/A
First received May 23, 2007
Last updated August 25, 2011
Start date May 2007
Est. completion date December 2009

Study information

Verified date August 2011
Source Children's Hospital Boston
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 17 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Low glycemic load diet
Outpatient behavioral counseling
Low fat diet
Outpatient behavioral counseling

Locations

Country Name City State
United States Children's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Boston

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary percent liver fat as determined by nMR spectroscopy 6 months No
Secondary hepatic steatosis as measured by T1 weighted MRI images 6 monhts No
Secondary visceral fat 6 months No
Secondary liver function tests 6 months No
Secondary measures of oxidative stress 6 months No
Secondary measures of chronic inflammation 6 months No
Secondary insulin resistance 6 months No
Secondary serum lipids 6 months No
Secondary blood pressure 6 months No
Secondary insulin secretion baseline No
Secondary measures of glucose tolerance 6 months No
Secondary adiponectin 6 months No
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