Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents

NCT ID: NCT02726542

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-03
• Study Completion Date: 2020-04-02

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.

Conditions

NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Growth hormone

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

Group Type: EXPERIMENTAL

somatropin

Intervention Type: DRUG

Norditropin (growth hormone) given by injection using a pen-device

No treatment

(no study treatment - observation only)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

somatropin

Norditropin (growth hormone) given by injection using a pen-device

Intervention Type: DRUG

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Takara Stanley

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Takara Stanley, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016p-000657

Identifier Type: -

Identifier Source: org_study_id