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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Growth hormone | Experimental | 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 | Placebo Comparator | Placebo will be administered by daily injection in this double blind study design. Sham dosing will be performed to maintain blinding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth hormone | Drug | growth hormone, Genotropin (Pfizer) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen K Miller, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Of the 131 people who signed a consent form, 78 were unable to participate due to various reasons including meeting ineligibility criteria. The 53 subjects who remained were randomized to one of two arms. One subject discontinued after randomization but before any baseline procedures were completed, leaving 52 subjects with available baseline data.
Subjects were recruited through hospital-wide and community advertisements between 2017-2021. Recruitment techniques included posting advertisements on the internet (i.e. Craigslist and Facebook) and on the Massachusetts General Hospital's clinical trial recruitment website.
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| ID | Title | Description |
|---|---|---|
| FG000 | Growth Hormone | Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered for 6 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range. |
| FG001 | Placebo | Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One subject discontinued after randomization but before any baseline procedures were completed, leaving 52 subjects with available baseline data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Growth Hormone | Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered for 6 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | percent liver fat | 6 months |
|
6 months
GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert.
GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk
# of events = # of subjects that experienced the side effect at any point during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Growth Hormone | Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered for 6 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated surgical procedure | Surgical and medical procedures | Systematic Assessment | unrelated SAE |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema | Blood and lymphatic system disorders | Systematic Assessment | (swelling) in the hands and/or feet |
We cannot extrapolate efficacy and safety to patients with diabetes mellitus.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen K. Miller | Massachusetts General Hospital | 617-726-3870 | kkmiller@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2022 | Sep 13, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2022 | Sep 13, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug | placebo with identical drug pen delivery device and packaging as Genotropin (Pfizer) |
|
| Adverse Event |
|
| Physician Decision |
|
| BG001 |
| Placebo |
Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mg/L | 6 months |
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| 15 |
| 24 |
| EG001 | Placebo | Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind. | 0 | 25 | 0 | 25 | 11 | 25 |
|
|
| Headache | General disorders | Systematic Assessment |
|
| Carpal Tunnel Syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint Pain or Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Numbness or tingling | Nervous system disorders | Systematic Assessment |
|
| Injection site discomfort or bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Allergic Reaction | Immune system disorders | Systematic Assessment |
|
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |