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The effect of orlistat in the treatment of non-alcoholic fatty liver in adolescents with overweight and obese

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Abstract

Nonalcoholic fatty liver disease (NAFLD), which can manifest as nonalcoholic steatohepatitis (NASH) or severe fibrosis, is the most prevalent chronic liver disease in children and adolescents. However, there is no proven cure for it so far. This study was conducted to determine whether adolescents with NAFLD would improve with treatment intervention with orlistat. This study is a randomized controlled trial (RCT). Fifty-three adolescents with overweight/obese as well as with NAFLD randomly allocated to receive orlistat (n = 27) or placebo as control (n = 26) for 12 weeks. In addition, NAFLD activity score, anthropometric factors, biochemical parameters including serum levels of lipid profiles, liver enzyme, and glucose metabolism taken from subjects at baseline and end of the study were investigated. The findings of our article indicated that orlistat improves liver enzymes (alanine transaminase and aspartate transaminase) (P =  < 0.001), steatosis score (P = 0.001), NAFLD activity score (P =  < 0.001), weight (P =  < 0.001), body mass index (BMI) (P =  < 0.001), waist circumferences (WC) (P =  < 0.001), BMI-Z score (P =  < 0.001), glucose metabolism (P = 0.001), total cholesterol (TC) (P = 0.009), low density lipoprotein-cholesterol (LDL) (P =  < 0.001), and high density lipoprotein-cholesterol HDL levels (P = 0.014) compared to the control group after adjusting for possible confounders for 12 weeks. However, no significant changes were observed on triglyceride (TG) following intake of orlistat compared to placebo after adjusting for confounders.

Conclusion: The findings of our study reported that orlistat improved NAFLD-related factors and metabolic syndrome-related factors compared to placebo for 12 weeks.

Trial Registration: (Clinical trial registry number: IRCT20220409054467N2, with a registration date of 2022–05-13).

What is Known:

• Among the interventions of interest for the management of pediatric NAFLD, we can mention lifestyle and pharmaceutical measures.

What is New:

• This study was conducted to determine whether adolescents with NAFLD would improve with treatment intervention with orlistat.

• The findings of our study reported that orlistat improved NAFLD-related factors and metabolic syndrome-related factors compared to placebo for 12 weeks.

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Acknowledgements

We express our appreciation to the participants of this study. This study is taken from the Obesity registry program in children at Tehran University of Medical Sciences (IR.TUMS.CHMC.REC.1401.016). We are thankful to Dr Mohammad Hassan Sohouli and Dr Afshin Ostovar, head of the obesity registry at Tehran University of Medical Sciences.

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Author notes

  1. Arefeh Zahmatkesh and Mohammad Hassan Sohouli contributed equally.

Authors and Affiliations

  1. School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Arefeh Zahmatkesh

  2. Student Research Committee, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Mohammad Hassan Sohouli

  3. Pediatric Gastroenterology and Hepatology Research Center, Pediatrics Centre of Excellence, Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran

    Mohammad Hassan Sohouli, Shima Shojaie & Pejman Rohani

Authors
  1. Arefeh Zahmatkesh
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  2. Mohammad Hassan Sohouli
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Contributions

P.R and Mh.S contributed in conception, design, and statistical analysis. A.Z., S.S, P.R, and MH.S contributed in data collection and manuscript drafting. P.R and MH.S supervised the study. All authors approved the final version of the manuscript.

Corresponding author

Correspondence to Pejman Rohani.

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Ethics approval and consent to participate

This study was approved by the research council and ethics committee Tehran University of Medical Sciences, Tehran, Iran (no: IR.TUMS.CHMC.REC.1401.016). The study has been registered in IRCT (IRCT20220409054467N2, with a registration date of 2022–05-13).

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Not applicable.

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The authors declare no competing interests.

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Communicated by Peter de Winter

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Zahmatkesh, A., Sohouli, M.H., Shojaie, S. et al. The effect of orlistat in the treatment of non-alcoholic fatty liver in adolescents with overweight and obese. Eur J Pediatr 183, 1173–1182 (2024). https://doi.org/10.1007/s00431-023-05369-3

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