Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00480922
Study type Interventional
Source Children's Hospital Boston
Contact
Status Completed
Phase N/A
Start date May 2007
Completion date December 2009

See also
  Status Clinical Trial Phase
Recruiting NCT05480696 - Soluble Fibre Supplementation in NAFLD Phase 1
Completed NCT05124847 - TREating Pediatric Obesity N/A
Recruiting NCT05499585 - Treating Pediatric NAFLD With Nutrition N/A
Completed NCT03717935 - Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS N/A
Active, not recruiting NCT02493153 - Hepatic Steatosis After Cholecystectomy N/A
Active, not recruiting NCT05654051 - The SLIM LIVER Study Phase 2
Completed NCT03334214 - Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes Phase 2
Recruiting NCT05599945 - First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases Phase 1
Enrolling by invitation NCT02816814 - Lacto-ovo-vegetarian Diet Riched in Omega-3 Fatty Acids in Menopausal Women N/A
Active, not recruiting NCT03587727 - Hepatic Mitochondrial Function in Youth
Not yet recruiting NCT06394206 - Benefit of a Hospital Intervention in Patients With Hepatic Steatosis N/A
Not yet recruiting NCT06363617 - Implementation of the Fatty Liver Index in Primary Care N/A
Not yet recruiting NCT05935826 - Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study) N/A
Recruiting NCT03142698 - Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis N/A
Not yet recruiting NCT05871749 - Effects of Hepatic Fibrosis on Hepatic Steatosis Using the Ultrasound Attenuation Imaging in Chronic Hepatitis B
Recruiting NCT05897073 - Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity N/A
Completed NCT03961516 - Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis
Completed NCT04180631 - Quantitative US for Hepatic Steatosis N/A
Terminated NCT00845845 - Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH) Phase 2
Completed NCT02814240 - Hepatic Steatosis and Pituitary Gland Failure, Evaluation by Nuclear Magnetic Resonance (NMR) Imaging N/A