Controlled Trial of WLS vs. CLI for Severely Obese Adolescents With NASH
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|ClinicalTrials.gov Identifier: NCT02412540|
Recruitment Status : Recruiting
First Posted : April 9, 2015
Last Update Posted : September 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease||Behavioral: Comprehensive Lifestyle Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Parallel Cohort Controlled Trial of Outcome of Nonalcoholic Steatohepatitis in Adolescents After Bariatric Surgery vs. Comprehensive Lifestyle Intervention (NASH ABC)|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
No Intervention: Weight Loss Surgery
Adolescents who will have Weight Loss Surgery and had biopsy-confirmed NASH. The Weight Loss Surgery is not part of the study. The investigators are following the adolescents after the surgery.
Experimental: Comprehensive Lifestyle Intervention
Comprehensive Lifestyle Intervention - Dietary, activity and behavioral interventions. Adolescents who have biopsy-confirmed NASH and wish to participate in a Comprehensive Lifestyle Intervention (26+ contact hours) including individual meetings with a study dietitian, group nutrition classes, behavior management modules and physical activity goals.
Behavioral: Comprehensive Lifestyle Intervention
Dietary, behavioral and activity interventions designed to reduce weight.
- Histology Endpoint: Proportion of subjects achieving greater than 2 point reduction in NASH activity score (NAS) [ Time Frame: 12 months ]Proportion of subjects achieving greater than 2 point reduction in NASH activity score (NAS) across at least two separate histological components of the NAS score (steatosis, inflammation and ballooning) and no worsening of fibrosis stage.
- Biomarker Endpoint [ Time Frame: 12 months ]Correlation between presence or absence of histological NASH and combined magnetic resonance (MR) measures and serum cytokeratin 18 (CK18) levels at baseline and 12 month follow-up.
- Resolution of NASH: Proportion of subjects achieving "not NASH" histological diagnosis [ Time Frame: 12 months ]Proportion of subjects achieving "not NASH" histological diagnosis at the end of the study.
- Reduction in mean NAS [ Time Frame: 12 months ]decrease in overall histological activity as measured by reduction in mean NAS.
- Decrease in steatosis [ Time Frame: 12 months ]Decrease in NAS score
- Composite decrease in weight [ Time Frame: 12 months ]Decrease in BMI, weight and waist circumference.
- Composite Quality of Life (QOL) Measures [ Time Frame: 12 months ]Change in generic health-related and weight-specific QOL measures Pediatric Quality of Life Inventory and Impact of Weight on Quality of Life (IWQOL-Kids©)).
- Liver enzymes [ Time Frame: 12 months ]Decrease in serum alanine (ALT) & asparate aminotransferase (AST), gamma-glutamyl trans-peptidase (GGT) level.
- Liver enzymes [ Time Frame: 12 months ]Normalization of ALT (defined as <26 U/L for males and <22 U/L for females).
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): NCT02412540
|Contact: Meghan McNeill, BS||(513)636-6226||Meghan.McNeil@cchmc.org|
|Contact: Stavra Xanthakos, MD||(513)636-4680||Stavra.Xanthakos@cchmc.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Meghan McNeill, BS 513-636-6226 Meghan.McNeill@cchmc.org|
|Contact: Stavra Xanthakos, MD 513-636-4680 Stavra.Xanthakos@cchmc.org|
|Principal Investigator: Stavra Xanthakos, MD|
|Principal Investigator:||Stavra Xanthakos, MD||Children's Hospital Medical Center, Cincinnati|