Fatty Liver Disease in Obese Children
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Peripheral Vascular Disease, Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Gastroenterology |
| Healthy: | No |
| Age Range: | 7 - 18 |
| Updated: | 4/2/2016 |
| Start Date: | April 2015 |
| End Date: | December 2017 |
| Contact: | Babu Balagopal, PhD |
| Email: | bbalagop@nemours.org |
| Phone: | 904-697-3822 |
Effect of N-acetyl Cysteine on Non Alcoholic Fatty Liver Disease in Obese Children
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.
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.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
