NCT02726542

Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 29 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NAFLD

Interventions

Type	Name	Description
DRUG	somatropin	Norditropin (growth hormone) given by injection using a pen-device

Timeline

• Start date: 2017-05-03
• Primary completion: 2020-04-02
• Completion: 2020-04-02
• First posted: 2016-04-01
• Last updated: 2022-09-07
• Results posted: 2021-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study