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Note: This study is currently only recruiting patients in the hospital.

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Effect of Growth Hormone on Liver Fat in Overweight Young Adults

This is a study for overweight or obese men and women ages 18-29 years old, to see if giving growth hormone will decrease the amount of fat in the liver and decrease markers of liver damage.

8 visits over 6 months
Estimated Time Commitment
Male, Female, 18-29 years
May Be Eligible
Payment up to $325, Meals
May Be Offered
Blood draw, Injection or IV, Medication, MRI scan, Survey
May Be Required
 
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This project is not recruiting.

What we are studying

Growth hormone is a hormone that regulates growth and metabolism.  We know from previous studies that people who are obese often have reduced growth hormone levels.  We also know from studies in animals that reductions in growth hormone change metabolism in the liver.  We think that reductions in growth hormone that often come with obesity contributes to disease called fatty liver disease.  


Fatty liver disease means there is a build-up of fat in the liver, which sometimes causes inflammation and damage to liver cells.  Healthy nutrition and exercise work to decrease fatty liver, but there are not many other treatments right now.  We are doing this study to see if growth hormone might work as a treatment for fatty liver disease in some people.


We are hoping to study young adults ages 18-29y who are obese and have reductions in growth hormone secretion as well as an increase in liver fat.  (We will test these things as part of the first study visit.) We will randomly assign half of the people in the study to receive growth hormone, which is given by injection using a pen device with a small needle.  The other half of people will be randomly assigned not to receive any medication.  People will participate in the study for 6 months, and we will see if, after 6 months, the people who got growth hormone have had improvements in their liver fat compared to the people who didn't get growth hormone. 


Why it is important


What we hope to accomplish

Principal Investigator

Takara Stanley, MD

Massachusetts General Hospital

Public Profile

Men and women between the ages of 18-29 years old who are overweight/obese.  (Body mass index needs to be above 30 kilogram per square meter.)  People in the study should have signs of reduced growth hormone and increased liver fat -- we will test both of these things at the first study visit.  


The following things would make someone NOT eligible for the study:  Drinking an average of more than 2 drinks/day for women or 3 drinks/day for men; Having diabetes or using insulin or pills for diabetes; Using steroids; Having alpha-1 antitrypsin deficiency, Wilson’s disease, hemochromatosis, or autoimmune hepatitis; Having hepatitis B or hepatitis C; Weighing less than 110 pounds; Not being able to have an MRI scan; Using weight loss medications or having weight loss surgery in the past; Being pregnant or breastfeeding; Having a history of cancer


 


Healthy Volunteers

Healthy volunteers are eligible for this study

Have an MRI scan to see how much liver fat they have.


Have tests of their growth hormone levels.


Do an oral glucose tolerance test, which is a 2 hour test that measures blood sugar.


Project activities may include:

  • Blood draw
  • Injection or IV
  • Medication
  • MRI scan
  • Survey

Estimated Time Commitment

8 visits over 6 months


Reimbursement for the cost of local transportation and parking.


Up to $325 in compensation for coming to study visits.

Massachusetts General Hospital Clinical Research Center
55 Fruit St., Boston, MA 02114

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Travel

  • Accessible by public transportation
  • Parking reimbursed
  • Local travel reimbursed

Travel and Parking Details


ClinicalTrials.gov Identifier

NCT02726542


Study Phase

Phase 1: This project studies the safety of a medication or treatment, usually on healthy volunteers. It examines the medication or treatment’s effects on the body and looks for side effects.


Participating Institutions


Funding Source

  • Industry
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