Status:
COMPLETED
Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Obesity
Eligibility:
FEMALE
13-21 years
Phase:
PHASE2
Brief Summary
Teenagers and adults who are overweight or obese have an increase in fat in the abdomen, which increases their risk for diabetes and heart disease. Reducing abdominal fat is important to reduce risk f...
Eligibility Criteria
Inclusion
- Adolescent girls 13-21 years old with bone age ≥ 14 years
- Overweight girls: Body Mass Index (BMI) greater than the 95th percentile for age
- Waist/Hip ratio ≥ 0.85
- Insulin Like Growth Factor -1 (IGF-1) below -0.5 standard deviations (SD) for pubertal stage or age
Exclusion
- Pregnancy (positive pregnancy test) prior to enrollment in the study
- Significant weight gain or loss within 3 months of study (more than 5 kg)
- Use of medications that affect GH or cortisol levels (such as estrogen including oral contraceptive pills, oral glucocorticoids)
- Use of medications such as Meridian and Orlistat
- Presence of diabetes mellitus
- Uncontrolled Thyroid disorders
- Chronic renal insufficiency
- Participation in another simultaneous medical investigation or trial
- Active neoplasm or history of cancer
- Prader-Willi syndrome
- History of scoliosis if bone age is \<15 years
- Hypersensitivity to rhGH or constituents of the injections
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01169103
Start Date
March 1 2010
End Date
December 1 2014
Last Update
November 2 2021
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114