Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480922
Status:
COMPLETED
Last Update Posted:
2011-08-26
First Post:
2007-05-23
Brief Title:
Effects of a Low Glycemic Load Diet on Fatty Liver in Children
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DELIVER
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None