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Sponsored by: |
Children's Hospital Boston |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00480922 |
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.
Condition | Intervention |
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Hepatic Steatosis |
Behavioral: Low glycemic load diet Behavioral: Low fat diet |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
A low glycemic load diet
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Behavioral: Low glycemic load diet
Outpatient behavioral counseling
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2: Active Comparator
Low fat diet
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Behavioral: Low fat diet
Outpatient behavioral counseling
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Ages Eligible for Study: | 8 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Children's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | David S Ludwig, MD, PhD | Children's Hospital Boston |
Responsible Party: | Children's Hospital Boston ( David Ludwig, MD, PhD ) |
Study ID Numbers: | 07-03-0092 |
Study First Received: | May 23, 2007 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00480922 History of Changes |
Health Authority: | United States: Federal Government |
non-alcoholic fatty liver disease steatohepatitis overweight insulin resistance |
Liver Diseases Non-alcoholic Steatohepatitis (NASH) Digestive System Diseases Overweight |
Fatty Liver Insulin Resistance Insulin |
Liver Diseases Digestive System Diseases Fatty Liver |