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NAFLD and Liver Fibrosis in Obese Adolescents

NCT04561804 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-09-24

No results posted yet for this study

Summary

Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease resulting from excessive fat accumulation in the liver. Due to its close association with obesity, it has become the most common liver disease in children in the United States. NAFLD can result in progressive fibrosis and lead to end-stage liver disease. Best practices in management of pediatric NAFLD are not clearly defined.

Our aim is to clarify the natural history of NAFLD in obese children after weight loss surgery compare to lifestyle intervention. Our secondary aim is to investigate the added value of elastography for the screening and diagnosis of NASH with fibrosis.

Conditions

Interventions

PROCEDURE

laparoscopic sleeve gastrectomy (LSG) and laparoscopic single anastomosis gastric bypass (LSAGB)

The participants will receive nutritional recommendations for a low carbohydrate, low glycemic load, and isocaloric diet. The diet will be composed of carbohydrates (CHO;35%), fats (40-50%), and proteins (20-25%), and will be tailored to individual preferences and calorie requirements. The number of CHO, protein and fat servings will be determined based on the recommended total energy requirements for age, calculated on the basis of dietary reference intake (DRI). Participants will not be instructed to restrict calories, but to reduce carbohydrate based on their glycemic load. The subjects will be instructed about appropriate food choices, and each subject was provided a diet information booklet containing food list, sample menus and recipes

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • sHLOMI Cohen, prof · Dana Dwek Children Hospital

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04561804 on ClinicalTrials.gov