Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents

NAFLD Clinical Trial

Official title:

Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726542
• Other study ID #: 2016p-000657
• Status: Completed
• Phase: Early Phase 1
• Start date: May 3, 2017
• Est. completion date: April 2, 2020

Study information

• Verified date: August 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2, 2020
• Est. primary completion date: April 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion criteria:

1. Males and Females ages 18-29yo

2. BMI =95th percentile and/or =30kg/m^2

3. Hepatic fat =5% by hydrogen magnetic resonance spectroscopy (1H-MRS)

4. IGF-1 standard deviation score (SDS) < 0

Exclusion criteria:

1. Alcohol consumption of >14 drinks per week (Females) or >21 drinks per week (Males)

2. Use of insulin or oral anti-diabetic medications, or hemoglobin A1c (HbA1c) >7% or fasting glucose =126mg/dL

3. Use of corticosteroid, gonadal steroids, or methotrexate = 3 months prior to baseline visit

4. Known diagnosis of alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, or autoimmune hepatitis

5. hemoglobin < 11.0 g/dL or weight < 50kg

6. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5x upper limit of normal (ULN), total bilirubin > ULN, positive hepatitis B surface antigen (sAg), or positive hepatitis C antibody

7. Routine magnetic resonance imaging (MRI) exclusion criteria (including weight >450 pounds)

8. Use of weight-loss medications or previous weight loss surgery

9. Pregnant or breastfeeding, or, for sexually-active females, unwillingness to use an appropriate form of contraception during the study

10. Known cirrhosis or clinical evidence of cirrhosis or portal hypertension on imaging or exam

11. Use of growth hormone (GH) or growth hormone releasing hormone within the past 1 year

12. Change in lipid lowering or anti-hypertensive medications within 3 months of screening

13. Change in vitamin E or ursodiol <6 months before screen; subjects on stable doses of Vitamin E and/or Ursodiol for =6 months will be eligible.

14. History of malignancy or active malignancy

15. History of hypopituitarism, head irradiation or any other condition or chronic illness known to affect the GH axis

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• somatropin
Norditropin (growth hormone) given by injection using a pen-device

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hepatic Fat Fraction	change in hepatic fat fraction between baseline and 24 weeks as measured by hydrogen magnetic resonance spectroscopy	24 weeks
Secondary	Change in Aspartate Aminotransferase (AST)	change in AST between baseline and 24 weeks	24 weeks
Secondary	Change in Alanine Aminotransferase (ALT)	change in ALT between baseline and 24 weeks	24 weeks
Secondary	Change in Gamma Glutamyl Transferase (GGT)	change in GGT between baseline and 24 weeks	24 weeks
Secondary	Change in Visceral Adipose Tissue	Change in visceral adipose tissue cross-sectional area at the 4th lumbar vertebra as measured by magnetic resonance imaging between baseline and 24 weeks	24 weeks