Growth Hormone Treatment on Phosphocreatine Recovery in Obesity

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Hideo Makimura, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01421589
First received: August 19, 2011
Last updated: May 29, 2014
Last verified: May 2014
Results First Received: March 31, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Obese
Growth Hormone Secretion Abnormality
Intervention: Drug: Growth hormone treatment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Growth Hormone Treatment Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.

Participant Flow:   Overall Study
    Growth Hormone Treatment  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Obese male subjects with reduced growth hormone secretion

Reporting Groups
  Description
Growth Hormone Growth hormone treatment: Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.

Baseline Measures
    Growth Hormone  
Number of Participants  
[units: participants]
  15  
Age  
[units: years]
Mean ± Standard Deviation
  47.9  ± 8.4  
Gender  
[units: participants]
 
Female     0  
Male     15  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     10  
More than one race     0  
Unknown or Not Reported     1  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     14  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Phosphocreatine Recovery   [ Time Frame: 12-weeks ]

2.  Secondary:   Change in Circulating IGF-1 Concentration   [ Time Frame: Baseline and 12-weeks ]

3.  Secondary:   Change in Skeletal Muscle IGF-1 Gene Expression   [ Time Frame: Baseline and 12-weeks ]

4.  Secondary:   Change in Body Composition   [ Time Frame: Baseline and 12-weeks ]

5.  Secondary:   Change in Inflammatory Marker   [ Time Frame: Baseline and 12-weeks ]

6.  Secondary:   Change in Insulin Sensitivity   [ Time Frame: Baseline and 12-weeks ]

7.  Secondary:   Change in Phosphocreatine Recovery   [ Time Frame: Baseline and 12-weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Hideo Makimura, MD, PhD
Organization: Massachusetts General Hospital
phone: 617-726-8277
e-mail: hmakimura@partners.org


No publications provided


Responsible Party: Hideo Makimura, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01421589     History of Changes
Other Study ID Numbers: 2011-P-000770
Study First Received: August 19, 2011
Results First Received: March 31, 2014
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board