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OpenTrials
Completed

NCT Number: NCT02217345

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

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).

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Key information

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18 - 65 yr
  • 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

  • Serum creatinine > 2 times the upper limit of normal
  • History of cancer, except for non-melanoma skin cancers
  • Active carpel tunnel syndrome
  • 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.
  • Contraindications to magnetic resonance imaging (MRI).
  • Pregnancy or desire to become pregnant. Participants of reproductive age must agree to use contraception.
  • Breastfeeding
  • Aspartate and aminotransferase levels >10x upper limit of normal

Treatment and study plan

growth hormone

Drug

growth hormone, Genotropin (Pfizer)

Other names: Genotropin (Pfizer Inc.)

Placebo

Drug

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

Primary outcomes

  1. Change in Intrahepatic Lipid Content Between Baseline and 6 Months as Measured by 1H-magnetic Resonance Spectroscopy (1H-MRS). Endpoints Were Assessed at Baseline and 6 Months.

    Time frame: 6 months

    Change in Intrahepatic lipid content by 1H-MRS over 6 months in the GH vs placebo group

Secondary outcomes

  1. Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months.

    Time frame: 6 months

    Change in serum high sensitivity C-reactive protein (hsCRP) (mg/L) between baseline and 6 months.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: NAFLD

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2014
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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