Primary outcomeMean· 24 weeks
Change in Hepatic Fat Fraction
| Group | Value (Percent (Hepatic fat fraction, percent)) | Spread |
|---|---|---|
| Growth Hormone | -3.0 | 5.2 |
| No Treatment | 0.3 | 3.5 |
Trial · Interventional
CompletedEarly phase 1Results postedRegistry dataAugmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents
NCTNCT02726542 (opens ClinicalTrials.gov in a new tab)Other id2016p-000657
Overview
- Status
- Completed
- Phase
- Early phase 1
- Enrollment
- 24 participants (actual)
- Sponsor
- Massachusetts General Hospital · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 3 May 2017
- Primary completion
- 2 Apr 2020
- Completion
- 2 Apr 2020
- First posted
- 1 Apr 2016 (estimated)
- Last update posted
- 7 Sept 2022
- Conditions
- NAFLD
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20172018201920202021
- Ph Early 1
Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents
NCT027265423 May 2017 to 2 Apr 2020
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- somatropinDrug
Arms2
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.
No intervention
No treatment
(no study treatment - observation only)
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Hepatic Fat Fraction
Time frame · 24 weeks
Registry description
change in hepatic fat fraction between baseline and 24 weeks as measured by hydrogen magnetic resonance spectroscopy
Secondary outcomes(4)
Change in Aspartate Aminotransferase (AST)
Time frame · 24 weeks
Registry description
change in AST between baseline and 24 weeks
Change in Alanine Aminotransferase (ALT)
Time frame · 24 weeks
Registry description
change in ALT between baseline and 24 weeks
Change in Gamma Glutamyl Transferase (GGT)
Time frame · 24 weeks
Registry description
change in GGT between baseline and 24 weeks
Change in Visceral Adipose Tissue
Time frame · 24 weeks
Registry description
Change in visceral adipose tissue cross-sectional area at the 4th lumbar vertebra as measured by magnetic resonance imaging between baseline and 24 weeks
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(4)
Secondary outcomeMean· 24 weeks
Change in Aspartate Aminotransferase (AST)
| Group | Value (units per liter) | Spread |
|---|---|---|
| Growth Hormone | -3 | 9 |
| No Treatment | -1 | 4 |
Secondary outcomeMean· 24 weeks
Change in Alanine Aminotransferase (ALT)
| Group | Value (units per liter) | Spread |
|---|---|---|
| Growth Hormone | -2 | 9 |
| No Treatment | 1 | 8 |
Secondary outcomeMean· 24 weeks
Change in Gamma Glutamyl Transferase (GGT)
| Group | Value (units per liter) | Spread |
|---|---|---|
| Growth Hormone | -9 | 30 |
| No Treatment | 5 | 9 |
Secondary outcomeMean· 24 weeks
Change in Visceral Adipose Tissue
| Group | Value (square centimeters) | Spread |
|---|---|---|
| Growth Hormone | -6 | 50 |
| No Treatment | 6 | 24 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Growth HormoneSomatropin given by daily subcutaneous injection. Dose will begin at 1mg and be titrated based on insulin-like growth factor 1 (IGF-1) levels. somatropin: Norditropin (growth hormone) given by injection using a pen-device | 0 / 13 | 1 / 13 | 9 / 13 |
| No Treatment(no study treatment - observation only) | 0 / 11 | 0 / 11 | 1 / 11 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 29 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
PepBank is a research reference. Talk to a doctor before you use any peptide.