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Trial record 45 of 342 for:    hepatic steatosis AND fat AND Nonalcoholic Fatty Liver

Fatty Liver Disease in Obese Children

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ClinicalTrials.gov Identifier: NCT02117700
Recruitment Status : Unknown
Verified March 2015 by Babu Balagopal, Nemours Children's Clinic.
Recruitment status was:  Not yet recruiting
First Posted : April 21, 2014
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Babu Balagopal, Nemours Children's Clinic

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.

Condition or disease Intervention/treatment Phase
Obesity Nonalcoholic Fatty Liver Disease Cardiovascular Disease Dietary Supplement: N-acetyl cysteine 600 mg once/day Dietary Supplement: N-acetyl cysteine 600mg twice/day Other: Placebo twice/day Phase 2

Detailed Description:
Physical activity (PA)-induced weight reduction, the suggested therapy for noalcoholic liver disease (NAFLD), is difficult and its maintenance is typically unsuccessful in children, affirming the acute need for alternative/adjunct therapies. Although few promising approaches have been reported, the benefits are incongruent and mostly marginal. N-acetyl cysteine (NAC), a derivative of the natural amino acid, cysteine, appears to be promising as an adjunct therapy to PA. Animal and a few adult human studies suggest NAC-induced attenuation of liver abnormalities, oxidative stress, insulin resistance and inflammation. The primary aim of the proposal is to determine in obese children with biopsy proven NASH and elevated liver enzymes the effect of NAC at two different doses on liver fat using magnetic resonance imaging (MRI), liver enzymes and risk factors of cardiometabolic disease. We hypothesize that NAC will produce beneficial effect on these parameters.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of N-acetyl Cysteine on Non Alcoholic Fatty Liver Disease in Obese Children
Study Start Date : April 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: N-acetyl cysteine-1
N-acetyl cysteine 600 mg once/day + Placebo once/day for 16 weeks
Dietary Supplement: N-acetyl cysteine 600 mg once/day
NAC 600 mg once/day + Placebo once/day for 16 weeks

Experimental: N-acetyl cysteine-2
N-acetyl cysteine 600 mg twice/day for 16 weeks
Dietary Supplement: N-acetyl cysteine 600mg twice/day
N-acetyl cysteine 600 mg twice/day for 16 weeks

Placebo Comparator: Placebo
Placebo twice/day for 16 weeks
Other: Placebo twice/day
Placebo capsules twice/day for 16 weeks




Primary Outcome Measures :
  1. Change in liver fat (MRI) and ALT levels from baseline and at 16 weeks [ Time Frame: Upto 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.


Other Outcome Measures:
  1. Change in Biomarkers of cardiovascular disease from baseline and at 16 weeks [ Time Frame: Upto 16 weeks ]
    The secondary outcome will be attenuation of abnormal levels of biomarkers of cardiovascular disease such as markers of inflammation, oxidative stress and insulin resistance. All measurements of biological factors will be performed in the post absorptive (fasted) state.



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117700


Contacts
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Contact: Babu Balagopal, PhD 904-697-3822 bbalagop@nemours.org
Contact: Vikas Uppal, MD 302-651-5962 vikas.uppal@nemours.org

Locations
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United States, Florida
Nemours Children's Clinic/Alfred I duPont Hospital Not yet recruiting
Jacksonville, Florida, United States, 32207
Contact: Babu Balagopal, PhD    904-697-3822    bbalagop@nemours.org   
Contact: Katryn Furuya, MD    302-651-5928    katryn.furuya@nemours.org   
Sub-Investigator: Vikas Uppal, MD         
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
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Principal Investigator: Babu Balagopal, PhD Nemours Children's Clinic

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Responsible Party: Babu Balagopal, Head, Obesity & Cardiovascular Research Laboratory, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT02117700     History of Changes
Other Study ID Numbers: NemoursCC
American Diabetes Association ( Other Grant/Funding Number: ADA1-14-CE-04 )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Babu Balagopal, Nemours Children's Clinic:
fatty liver
obesity
children
oxidative stress
antioxidants

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Cardiovascular Diseases
Digestive System Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes