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OpenTrials
Completed

NCT Number: NCT00480922

Effects of a Low Glycemic Load Diet on Fatty Liver in Children

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.

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Key information

Conditions

Hepatic Steatosis Body Weight Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Glycemic Load diet

Behavioral

Outpatient behavioral counseling

Low Fat Diet

Behavioral

Outpatient behavioral counseling

Primary outcomes

  1. percent liver fat as determined by nMR spectroscopy

    Time frame: 6 months

Secondary outcomes

  1. hepatic steatosis as measured by T1 weighted MRI images

    Time frame: 6 monhts

  2. visceral fat

    Time frame: 6 months

  3. liver function tests

    Time frame: 6 months

  4. measures of oxidative stress

    Time frame: 6 months

  5. measures of chronic inflammation

    Time frame: 6 months

  6. insulin resistance

    Time frame: 6 months

  7. serum lipids

    Time frame: 6 months

  8. blood pressure

    Time frame: 6 months

  9. insulin secretion

    Time frame: baseline

  10. measures of glucose tolerance

    Time frame: 6 months

  11. adiponectin

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study 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

Acronym: DELIVER

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 31, 2007
Registry last updated
Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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