Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02726542 |
Recruitment Status
:
Recruiting
First Posted
: April 1, 2016
Last Update Posted
: January 10, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
NAFLD | Drug: somatropin | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents |
Actual Study Start Date : | May 3, 2017 |
Estimated Primary Completion Date : | September 2019 |
Estimated Study Completion Date : | September 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Growth hormone
Somatropin given by daily subcutaneous injection. Dose will begin at 1mg and be titrated based on insulin-like growth factor 1 (IGF-1) levels.
|
Drug: somatropin
Norditropin (growth hormone) given by injection using a pen-device
|
No Intervention: No treatment
(no study treatment - observation only)
|
- Change in hepatic fat [ Time Frame: 24 weeks ]change in hepatic fat as measured by hydrogen magnetic resonance spectroscopy
- Change in aspartate aminotransferase (AST) [ Time Frame: 24 weeks ]
- Change in alanine aminotransferase (ALT) [ Time Frame: 24 weeks ]
- Change in gamma glutamyl transferase [ Time Frame: 24 weeks ]
- Change in visceral adipose tissue [ Time Frame: 24 weeks ]Change in visceral adipose tissue volume as measured by magnetic resonance imaging

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Ages Eligible for Study: | 18 Years to 29 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Males and Females ages 18-29yo
- BMI ≥95th percentile and/or ≥30kg/m^2
- Hepatic fat ≥5% by hydrogen magnetic resonance spectroscopy (1H-MRS)
- IGF-1 standard deviation score (SDS) < 0
Exclusion criteria:
- Alcohol consumption of >14 drinks per week (Females) or >21 drinks per week (Males)
- Use of insulin or oral anti-diabetic medications, or hemoglobin A1c (HbA1c) >7% or fasting glucose ≥126mg/dL
- Use of corticosteroid, gonadal steroids, or methotrexate ≤ 3 months prior to baseline visit
- Known diagnosis of alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, or autoimmune hepatitis
- hemoglobin < 11.0 g/dL or weight < 50kg
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5x upper limit of normal (ULN), total bilirubin > ULN, positive hepatitis B surface antigen (sAg), or positive hepatitis C antibody
- Routine magnetic resonance imaging (MRI) exclusion criteria (including weight >450 pounds)
- Use of weight-loss medications or previous weight loss surgery
- Pregnant or breastfeeding, or, for sexually-active females, unwillingness to use an appropriate form of contraception during the study
- Known cirrhosis or clinical evidence of cirrhosis or portal hypertension on imaging or exam
- Use of growth hormone (GH) or growth hormone releasing hormone within the past 1 year
- Change in lipid lowering or anti-hypertensive medications within 3 months of screening
- Change in vitamin E or ursodiol <6 months before screen; subjects on stable doses of Vitamin E and/or Ursodiol for ≥6 months will be eligible.
- History of malignancy or active malignancy
- History of hypopituitarism, head irradiation or any other condition or chronic illness known to affect the GH axis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726542
Contact: Takara Stanley, MD | 617-726-5312 | tstanley@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Takara L. Stanley, MD 617-726-5312 tstanley@partners.org |
Principal Investigator: | Takara Stanley, MD | Massachusetts General Hospital |
Responsible Party: | Takara Stanley, M.D., Assistant Professor of Pediatrics, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT02726542 History of Changes |
Other Study ID Numbers: |
2016p-000657 |
First Posted: | April 1, 2016 Key Record Dates |
Last Update Posted: | January 10, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Takara Stanley, M.D., Massachusetts General Hospital:
obesity adolescence fatty liver growth hormone |
Additional relevant MeSH terms:
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |