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

Primary Purpose

Nonalcoholic Fatty Liver Disease (NAFLD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Growth hormone
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease (NAFLD)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Growth hormone

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months.
Change in serum high sensitivity C-reactive protein (hsCRP) (mg/L) between baseline and 6 months.

Full Information

First Posted
July 15, 2014
Last Updated
October 28, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02217345
Brief Title
Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Acronym
NAFLD
Official Title
Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
September 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease (NAFLD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Growth hormone
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered by daily injection in this double blind study design. Sham dosing will be performed to maintain blinding.
Intervention Type
Drug
Intervention Name(s)
Growth hormone
Other Intervention Name(s)
Genotropin (Pfizer Inc.)
Intervention Description
growth hormone, Genotropin (Pfizer)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo with identical drug pen delivery device and packaging as Genotropin (Pfizer)
Primary Outcome Measure Information:
Title
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.
Description
Change in Intrahepatic lipid content by 1H-MRS over 6 months in the GH vs placebo group
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months.
Description
Change in serum high sensitivity C-reactive protein (hsCRP) (mg/L) between baseline and 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen K Miller, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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

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