Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease

NCT ID: NCT02217345

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-02
• Study Completion Date: 2021-09-13

Brief Summary

Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates of about 30% of individuals in the United States. A subset of these will develop progressive disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy (1H-MRS).

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Growth hormone

Growth hormone (somatropin) administered by daily injection at starting dose of 0.3 mg daily for women and 0.2 mg daily for men, with dose titration for goal IGF-1 in the upper quartile of normal for age.

Group Type: EXPERIMENTAL

Growth hormone

Intervention Type: DRUG

growth hormone, Genotropin (Pfizer)

Placebo

Placebo will be administered by daily injection in this double blind study design. Sham dosing will be performed to maintain blinding.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo with identical drug pen delivery device and packaging as Genotropin (Pfizer)

Interventions

Growth hormone

growth hormone, Genotropin (Pfizer)

Intervention Type: DRUG

Placebo

placebo with identical drug pen delivery device and packaging as Genotropin (Pfizer)

Intervention Type: DRUG

Other Intervention Names

Genotropin (Pfizer Inc.)

Eligibility Criteria

Inclusion Criteria

1. Ages 18 - 65 yr

2. NAFLD defined as demonstration of hepatic steatosis by imaging or biopsy in absence of significant alcohol consumption and other causes of hepatic steatosis. If liver imaging or biopsy has not been performed clinically, liver ultrasound will be performed as part of the screening visit.

Exclusion Criteria

1. Serum creatinine > 2 times the upper limit of normal

2. History of cancer, except for non-melanoma skin cancers

3. Active carpel tunnel syndrome

4. Diabetes mellitus, defined as a hemoglobin A1C >6.5 or use of any medications prescribed to treat hyperglycemia. The exception is that the use of metformin is acceptable in patients whose HbA1c has been =<6.0 on two visits and whose weight has remained stable for six months.

5. Contraindications to magnetic resonance imaging (MRI).

6. Pregnancy or desire to become pregnant. Participants of reproductive age must agree to use contraception.

7. Breastfeeding

8. Aspartate and aminotransferase levels >10x upper limit of normal

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karen Klahr Miller, MD

Neuroendocrine Unit Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen K Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014P001680

Identifier Type: -

Identifier Source: org_study_id