Clinical trials: Steatosis
Non-Alcoholic Fatty Liver Disease
Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study
Over the past 30 years, the prevalence of childhood obesity in the United States has tripled from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes, cardiovascular disease and nonalcoholic…
- Trial name
- NCT01285362
- Testing
- Fish Oil Supplementation
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Columbia University
Non-Alcoholic Fatty Liver Disease
Gemcabene for the Treatment of Pediatric NAFLD
This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by…
- Trial name
- NCT03436420
- Testing
- Gemcabene
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Emory University
Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study
This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease…
- Trial name
- NCT04800094
- Testing
- Investigational Liver Fat Quantification Software
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Non Alcoholic Steatohepatitis
Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)
The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams [mg] and 120mg) during 3 months in children…
- Trial name
- NCT03883607
- Testing
- Elafibranor 80mg, Elafibranor 120mg
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Genfit
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Fatty Liver
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.
- Trial name
- TONIC (NCT00063635)
- Testing
- Metformin, Vitamin E
- Where
- 10 sites in United States
- Volunteers
- 173 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Polycystic Ovarian Syndrome, Obesity
Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS
The Investigators will measure hepatic glucose and fat metabolism in obese girls with Polycystic Ovarian Syndrome (PCOS) and hepatic steatosis (HS) after taking 4 weeks of an essential amino acid (EAA) supplement or placebo and…
- Conditions
- Polycystic Ovarian Syndrome, Obesity, Hepatic Steatosis
- Trial name
- ORANGE (NCT03717935)
- Testing
- Essential Amino Acid (EAA) Supplement
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of Colorado, Denver
Polycystic Ovarian Syndrome, Obesity
Post-Prandial Liver Glucose Metabolism in PCOS
The Investigators will measure if hepatic metabolism is upregulated in obese girls with PCOS and hepatic steatosis (HS), compared to PCOS without HS and obese controls without HS.
- Conditions
- Polycystic Ovarian Syndrome, Obesity, Hepatic Steatosis
- Trial name
- PLUM (NCT03041129)
- Testing
- oral glucose tolerance test, MRI of liver
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Nonalcoholic Fatty Liver Disease (NAFLD)
Anti-LPS Antibody Treatment for Pediatric NAFLD
The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care treatment will decrease inflammation in the liver…
- Trial name
- NCT03042767
- Testing
- IMM-124E
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Miriam Vos, MD
Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease
Ultrasound Method to Measure Fibrosis of the Liver in Children
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease.
- Conditions
- Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, HCV Coinfection, HBV
- Trial name
- NCT02086708
- Testing
- Shear Wave sonoelastography
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Massachusetts General Hospital
Non-Alcoholic Fatty Liver Disease, Insulin Resistance
Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD).
- Conditions
- Non-Alcoholic Fatty Liver Disease, Insulin Resistance, High Intensity Interval Training, Childhood Obesity
- Trial name
- NCT04342390
- Testing
- High-Intensity Interval Training (HIIT)
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Arkansas Children's Hospital Research Institute
Morbid Obesity, Obstructive Sleep Apnea Syndrome
LAGB as a Treatment for Morbid Obesity in Adolescents
Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older.
- Conditions
- Morbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome, Insulin Resistance
- Trial name
- NCT01045499
- Testing
- Laparoscopic adjustable gastric banding (Allergan Lap Band)
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- Jeffrey L Zitsman, MD
Nonalcoholic Fatty Liver Disease (NAFLD)
Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children
CyNCh is a multi-center, placebo-controlled clinical trial of children ages 8 to 17 years with biopsy-confirmed moderate to severe nonalcoholic fatty liver disease (NAFLD).
- Trial name
- CyNCh (NCT01529268)
- Testing
- DR cysteamine bitartrate capsule
- Where
- 10 sites in United States
- Volunteers
- 169 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Fatty Liver Disease, Nonalcoholic, Nonalcoholic Steatohepatitis
Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy
This study involves research about an investigational medicine called metreleptin. The reason for this study is to find out how metreleptin can improve non-alcoholic steatohepatitis or nonalcoholic fatty liver disease associated…
- Conditions
- Fatty Liver Disease, Nonalcoholic, Nonalcoholic Steatohepatitis, Lipodystrophy
- Trial name
- NCT01679197
- Testing
- Metreleptin
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of Michigan
Pediatric Obesity, NAFLD
Effect of Obesity on Proton Pump Inhibitors
This longitudinal study tests the hypothesis that obesity affects drug pharmacology of acid suppression medications in children.
- Conditions
- Pediatric Obesity, NAFLD, GERD
- Trial name
- LiverLabPPI (NCT04248335)
- Testing
- Lansoprazole, Pantoprazole, Midazolam
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City
Hepatic Steatosis, Polycystic Ovarian Syndrome
Liver and Fat Regulation in Overweight Adolescent Girls
Women with polycystic ovarian syndrome (PCOS) have increased rates of hepatic steatosis compared to weight similar women with regular menses. It is unclear if this is related to high testosterone or insulin resistance.
- Conditions
- Hepatic Steatosis, Polycystic Ovarian Syndrome, Obesity
- Trial name
- APPLE (NCT02157974)
- Testing
- Byetta 5Mcg Pen Injection
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
PCOS, Adolescent Obesity
Treating PCOS With Semaglutide vs Active Lifestyle Intervention
Girls with obesity and polycystic ovarian syndrome will receive either glucagon like peptide-1 receptor agonist therapy or a dietary intervention for 12 weeks to decrease the metabolic syndrome, in particular to lower hepatic fat…
- Conditions
- PCOS, Adolescent Obesity, NAFLD
- Trial name
- TEAL (NCT03919929)
- Testing
- Semaglutide 3mg and 7mg [Rybelsus], Weight loss diet
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Colorado, Denver
Nonalcoholic Fatty Liver Disease
Dietary Treatment Study of Pediatric NAFLD
This is an investigator initiated study being conducted in equal numbers at two sites, University of California, San Diego (UC San Diego) and Emory University (EU).
- Trial name
- DTS (NCT02513121)
- Testing
- Dietary modification
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
Hepatic Steatosis, Bariatric Surgery Candidate
Hepatic Mitochondrial Function in Youth
Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth
- Conditions
- Hepatic Steatosis, Bariatric Surgery Candidate, Adolescent Obesity, Obesity
- Trial name
- MANGO (NCT03587727)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
NAFLD
Study of Losartan in the Treatment of NAFLD in Children
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease among children and is closely associated with obesity and the metabolic syndrome.
- Trial name
- NCT01913470
- Testing
- Losartan
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Miriam Vos, MD