Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents

• Status: Completed
• Trial end date: 2020-04-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Hormones

Criteria

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