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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)

Treatments: Drug: Growth hormone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02217345

2014P001680

Details and patient eligibility

About

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).

Enrollment: 131 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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131 participants in 2 patient groups, including a placebo group

Growth hormone

Experimental group

Description:

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.

Treatment:

Drug: Growth hormone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo