Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents

Early Phase 1

Completed

• Conditions: NAFLD
• Interventions: Drug: somatropin

• Registration Number: NCT02726542
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Fatty liver disease is an increasing problem in overweight and obese young adults. The purpose of this study is to test the effect of growth hormone on liver fat in obese young adults ages 18-29y with increased liver fat.

Detailed Description

Non-alcoholic fatty liver disease (NAFLD) is a significant health problem in obese adolescents. Obese children and adolescents have significant reductions in growth hormone secretion, and we hypothesize that augmenting growth hormone in this population will decrease liver fat. Growth hormone inhibits hepatic de novo lipogenesis, which is an important source of hepatic lipid. Patients with pituitary GH deficiency have a higher prevalence of NAFLD and non-alcoholic steatohepatitis (NASH) than the general population, and replacement of GH in these individuals reduces signs of liver damage. The purpose of this study is to test the hypothesis that growth hormone treatment will decrease liver fat quantity in young adults who begin the trial with more than 5% liver fat measured by magnetic resonance spectroscopy.

Study Timeline

• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-01
• Study Start: 2017-05-03
• Primary Completion: 2020-04-02
• Study Completion: 2020-04-02
• Results First Submitted: 2021-03-29
• Results First Submitted QC: 2021-03-29
• Results First Posted: 2021-04-26
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Growth hormone	somatropin	Somatropin given by daily subcutaneous injection. Dose will begin at 1mg and be titrated based on insulin-like growth factor 1 (IGF-1) levels.

Primary Outcome Measures

Name	Time	Method
Change in Hepatic Fat Fraction	24 weeks	change in hepatic fat fraction between baseline and 24 weeks as measured by hydrogen magnetic resonance spectroscopy

Secondary Outcome Measures

Name	Time	Method
Change in Aspartate Aminotransferase (AST)	24 weeks	change in AST between baseline and 24 weeks
Change in Visceral Adipose Tissue	24 weeks	Change in visceral adipose tissue cross-sectional area at the 4th lumbar vertebra as measured by magnetic resonance imaging between baseline and 24 weeks
Change in Alanine Aminotransferase (ALT)	24 weeks	change in ALT between baseline and 24 weeks
Change in Gamma Glutamyl Transferase (GGT)	24 weeks	change in GGT between baseline and 24 weeks

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States