Fatty Liver Disease in Obese Children

NCT02117700 | Completed Phase 1 DMC

• 2 other identifiers: NemoursCCAmerican Diabetes Association
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Although weight reduction through physical activity-based interventions is the mainstay therapy for nonalcoholic fatty liver disease (NAFLD), its maintenance is difficult and typically unsuccessful. This affirms the extreme need for alternate and/or adjunct therapies. Although convincing data from animal studies and a few adult human studies on the benefits of a natural product, N-acetyl cysteine (NAC), in a variety of liver conditions including NAFLD have emerged, studies in children are scarce. Therefore, the aim of the study is to test the use NAC as an innovative approach to attenuate the progression of NAFD in obese children with biopsy proven NASH. The central hypothesis is that NAC supplementation will reduce liver fat and liver enzymes and ameliorate risk factors of cardiometabolic disease in children with NAFLD.

Conditions

Obesity; Nonalcoholic Fatty Liver Disease; Cardiovascular Disease

Keywords

fatty liver; obesity; children; oxidative stress; antioxidants

Outcome Measures

Primary Outcomes (1)

• Change in liver fat (MRI) and ALT levels from baseline and at 16 weeks

  The primary outcome will be sustained reduction in ALT level, defined as 50% or less of the baseline level or 40 U/L or less and significant changes in liver fat (MRI) at the end of the study. All measurements of biological factors will be performed in the post absorptive (fasted) state.

  Upto 16 weeks

Other Outcomes (1)

• Change in Biomarkers of cardiovascular disease from baseline and at 16 weeks

  Upto 16 weeks

Study Arms (3)

N-acetyl cysteine-1

EXPERIMENTAL

N-acetyl cysteine 600 mg once/day + Placebo once/day for 16 weeks

Dietary Supplement: N-acetyl cysteine 600 mg once/day

N-acetyl cysteine-2

EXPERIMENTAL

N-acetyl cysteine 600 mg twice/day for 16 weeks

Dietary Supplement: N-acetyl cysteine 600mg twice/day

Placebo

PLACEBO COMPARATOR

Placebo twice/day for 16 weeks

Other: Placebo twice/day

Interventions

N-acetyl cysteine 600 mg once/day DIETARY_SUPPLEMENT

NAC 600 mg once/day + Placebo once/day for 16 weeks

N-acetyl cysteine-1

N-acetyl cysteine 600mg twice/day DIETARY_SUPPLEMENT

N-acetyl cysteine 600 mg twice/day for 16 weeks

N-acetyl cysteine-2

Placebo twice/day OTHER

Placebo capsules twice/day for 16 weeks

Placebo

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 7 years and older
• NASH confirmed in a previous biopsy
• HbAIc \<6.4%
• ALT \> 60 U/L or 1.5 times the upper limit of normal

You may not qualify if:

• Chronic liver disease including alpha-1-antitrypsin deficiency, Wilson's disease, autoimmune and viral hepatitis
• Medications such as adrenergic β-blockers, steroids and other drugs known to interfere with the measurement of liver enzymes and risk factors for cardiovascular disease
• Heart disease, chronic renal disease, adrenal, hepatic or thyroid dysfunction; active malignancy; and anemia
• History of prior treatment with NAC
• Evidence of hypersensitivity/allergy to NAC
• Alcoholism or drug abuse and smoking
• Inter-current illness over 7 days before the study \& surgery in the past 3 mo.

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Clinic/Alfred I duPont Hospital

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease; Cardiovascular Diseases; Fatty Liver

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Babu Balagopal, PhD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo controlled randomized double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Obesity & Cardiovascular Research Laboratory

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2020
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)