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Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents

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ClinicalTrials.gov Identifier: NCT02726542
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Takara Stanley, M.D., Massachusetts General Hospital

Study Description
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Brief Summary:
Fatty liver disease is an increasing problem in overweight and obese young adults. The purpose of this study is to test the effect of growth hormone on liver fat in obese young adults ages 18-29y with increased liver fat.

Condition or disease Intervention/treatment Phase
NAFLD Drug: somatropin Early Phase 1

Detailed Description:
Non-alcoholic fatty liver disease (NAFLD) is a significant health problem in obese adolescents. Obese children and adolescents have significant reductions in growth hormone secretion, and we hypothesize that augmenting growth hormone in this population will decrease liver fat. Growth hormone inhibits hepatic de novo lipogenesis, which is an important source of hepatic lipid. Patients with pituitary GH deficiency have a higher prevalence of NAFLD and non-alcoholic steatohepatitis (NASH) than the general population, and replacement of GH in these individuals reduces signs of liver damage. The purpose of this study is to test the hypothesis that growth hormone treatment will decrease liver fat quantity in young adults who begin the trial with more than 5% liver fat measured by magnetic resonance spectroscopy.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Change in hepatic fat [ Time Frame: 24 weeks ]
    change in hepatic fat as measured by hydrogen magnetic resonance spectroscopy


Secondary Outcome Measures :
  1. Change in aspartate aminotransferase (AST) [ Time Frame: 24 weeks ]
  2. Change in alanine aminotransferase (ALT) [ Time Frame: 24 weeks ]
  3. Change in gamma glutamyl transferase [ Time Frame: 24 weeks ]
  4. Change in visceral adipose tissue [ Time Frame: 24 weeks ]
    Change in visceral adipose tissue volume as measured by magnetic resonance imaging


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Males and Females ages 18-29yo
  2. BMI ≥95th percentile and/or ≥30kg/m^2
  3. Hepatic fat ≥5% by hydrogen magnetic resonance spectroscopy (1H-MRS)
  4. IGF-1 standard deviation score (SDS) < 0

Exclusion criteria:

  1. Alcohol consumption of >14 drinks per week (Females) or >21 drinks per week (Males)
  2. Use of insulin or oral anti-diabetic medications, or hemoglobin A1c (HbA1c) >7% or fasting glucose ≥126mg/dL
  3. Use of corticosteroid, gonadal steroids, or methotrexate ≤ 3 months prior to baseline visit
  4. Known diagnosis of alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, or autoimmune hepatitis
  5. hemoglobin < 11.0 g/dL or weight < 50kg
  6. 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
  7. Routine magnetic resonance imaging (MRI) exclusion criteria (including weight >450 pounds)
  8. Use of weight-loss medications or previous weight loss surgery
  9. Pregnant or breastfeeding, or, for sexually-active females, unwillingness to use an appropriate form of contraception during the study
  10. Known cirrhosis or clinical evidence of cirrhosis or portal hypertension on imaging or exam
  11. Use of growth hormone (GH) or growth hormone releasing hormone within the past 1 year
  12. Change in lipid lowering or anti-hypertensive medications within 3 months of screening
  13. 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.
  14. History of malignancy or active malignancy
  15. History of hypopituitarism, head irradiation or any other condition or chronic illness known to affect the GH axis
Contacts and Locations
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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


Contacts
Contact: Takara Stanley, MD 617-726-5312 tstanley@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Takara L. Stanley, MD    617-726-5312    tstanley@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Takara Stanley, MD Massachusetts General Hospital
More Information
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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