NAFLD and Liver Fibrosis in Obese Adolescents

NCT04561804 | Completed

• 1 other identifier: 0097-17-TLV
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Liver Fibrosis; Liver Steatosis; Weight Loss

Outcome Measures

Primary Outcomes (1)

• change in liver fibrosis

  Liver fibrosis will be estimated by Shearwave elastography (Supersonic) and categorized into 4 levels, F0-F4, according to liver stiffness

  3 and 6 months

Secondary Outcomes (2)

• change in liver steatosis

  3 and 6 months

• weight reduction

  3 and 6 months

Study Arms (2)

LISESTYLE INTERVENTION

LOW CARB LOW GLYCEMIC LOAS DIET

WEGHT LOSS SURGERY

SLEEVE OR MINBYPASS SURGERY

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

Interventions

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

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

Also known as: Dietary intervention

WEGHT LOSS SURGERY

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We prospectively recruited all children and adolescents (age 7-18 years) with obesity who were admitted to the Obesity clinic at Dana-Dwek Children's Hospital of the Tel Aviv Medical Center between December 1, 2018, and December 1, 2019. All children with a BMI \>95 percentile for age were included in the study.

You may qualify if:

• Age 13-18 years.
• No other chronic disease except the metabolic syndrome.
• Not taking any medication

You may not qualify if:

• Children that are known to suffer from genetic/metabolic disorders that can cause steatosis- Wilson disease, hypothyroidism, autoimmune hepatitis, Alpha 1 antitrypsin.
• Children infected with HBV or HCV, HAV.
• Children that use medications that can cause liver steatosis- amiodarone, MTX, Corticosteroids
• Children with significant ethanol consumption -\>10 gr per day for women and \>20gr per day for men.
• Pregnant women.
• Obesity due to syndromes or monogenic disease
• General withdraw criteria:
• If the participant withdraws his consent.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Pediatric Gastroenterology

Tel Aviv, Israel

Location

Related Publications (1)

• Moran-Lev H, Cohen S, Webb M, Yerushalmy-Feler A, Amir A, Gal DL, Lubetzky R. Higher BMI predicts liver fibrosis among obese children and adolescents with NAFLD - an interventional pilot study. BMC Pediatr. 2021 Sep 3;21(1):385. doi: 10.1186/s12887-021-02839-1.

  PMID: 34479517 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Fatty Liver; Weight Loss

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• sHLOMI Cohen, prof

  Dana Dwek Children Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Shlomi Cohen

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 24, 2020
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)