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Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Madhusmita Misra, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01169103
First received: July 22, 2010
Last updated: April 6, 2015
Last verified: April 2015
History of Changes
Results First Received: December 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Participant);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Drug: recombinant human growth hormone (rhGH)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at Massachusetts General Hospital between September 2010 and October 2012 through area pediatric and obesity clinics and advertisements.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 32 subjects who were screened, 22 were eligible & randomized. 5 subjects were ineligible due to Insulin Like Growth Factor levels above the eligibility limit for pubertal stage or age. 2 were excluded due to planned initiation of medications that were on the exclusion criteria list and 3 voluntarily withdrew consent prior to randomization.

Reporting Groups
  Description
Recombinant Human Growth Hormone

Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.

recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
Placebo/no Treatment

Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.

Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment.

Participant Flow:   Overall Study
    Recombinant Human Growth Hormone   Placebo/no Treatment
STARTED   11   11 
COMPLETED   5   7 
NOT COMPLETED   6   4 
Lost to Follow-up                3                3 
Withdrawal by Subject                3                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Recombinant Human Growth Hormone

Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.

recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
Placebo/no Treatment

Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.

Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment.
Total Total of all reporting groups

Baseline Measures
   Recombinant Human Growth Hormone   Placebo/no Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 11   11   22 
Age 
[Units: Participants]
 		     
<=18 years   9   8   17 
Between 18 and 65 years   2   3   5 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 16.2  (2.6)   16.9  (2.1)   16.6  (2.34) 
Gender 
[Units: Participants]
 		     
Female   11   11   22 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
 		     
United States   11   11   22 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months   [ Time Frame: Baseline and 6 months ]
  Show Outcome Measure 1

2.  Primary:   Changes in Lipid Panel   [ Time Frame: Baseline and 6 months ]
  Show Outcome Measure 2

3.  Primary:   Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months   [ Time Frame: Baseline and 6 months ]
  Show Outcome Measure 3

4.  Primary:   Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months   [ Time Frame: Baseline and 6 months ]
  Show Outcome Measure 4

5.  Secondary:   Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score   [ Time Frame: Baseline and 6 months ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Madhusmita Misra
Organization: Massachusetts General Hospital
phone: 617-724-5602
e-mail: mmisra@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Madhusmita Misra, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01169103     History of Changes
Other Study ID Numbers: 2009P000861
Study First Received: July 22, 2010
Results First Received: December 10, 2013
Last Updated: April 6, 2015