NCT02726542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2017

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 3, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 26, 2021

Completed
Last Updated

September 7, 2022

Status Verified

August 1, 2022

Enrollment Period

2.9 years

First QC Date

March 30, 2016

Results QC Date

March 29, 2021

Last Update Submit

August 11, 2022

Conditions

NAFLD

Keywords

obesityadolescencefatty livergrowth hormone

Outcome Measures

Primary Outcomes (1)

  • Change in Hepatic Fat Fraction

    change in hepatic fat fraction between baseline and 24 weeks as measured by hydrogen magnetic resonance spectroscopy

    24 weeks

Secondary Outcomes (4)

  • Change in Aspartate Aminotransferase (AST)

    24 weeks

  • Change in Alanine Aminotransferase (ALT)

    24 weeks

  • Change in Gamma Glutamyl Transferase (GGT)

    24 weeks

  • Change in Visceral Adipose Tissue

    24 weeks

Study Arms (2)

Growth hormone

EXPERIMENTAL

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

No treatment

NO INTERVENTION

(no study treatment - observation only)

Interventions

somatropinDRUG

Norditropin (growth hormone) given by injection using a pen-device

Growth hormone

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesityFatty Liver

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Takara Stanley, MD
Organization
Massachusetts General Hospital
tstanley@mgh.harvard.edu
617-726-5312

Study Officials

  • Takara Stanley, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 1, 2016

Study Start

May 3, 2017

Primary Completion

April 2, 2020

Study Completion

April 2, 2020

Last Updated

September 7, 2022

Results First Posted

April 26, 2021

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)