Ghrelin Levels in Children With Poor Growth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jordan Pinsker, Tripler Army Medical Center
ClinicalTrials.gov Identifier:
NCT01070173
First received: February 12, 2010
Last updated: January 15, 2013
Last verified: January 2013
Results First Received: December 8, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Idiopathic Short Stature
Failure to Thrive

  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
Fifty-two patients were recruited into the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
Short Stature Poor linear growth Group
Poor Weight Gain (Failure-To-Thrive) Poor Weight Gain (Failure-To-Thrive) Group
Isolated Gastrointestinal Symptoms Isolated Gastrointestinal Symptoms Group

Participant Flow:   Overall Study
    Short Stature     Poor Weight Gain (Failure-To-Thrive)     Isolated Gastrointestinal Symptoms  
STARTED     33     8     11  
COMPLETED     33     8     11  
NOT COMPLETED     0     0     0  



  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
Short Stature Poor linear growth
Poor Weight Gain (Failure-To-Thrive) Poor Weight Gain (Failure-To-Thrive)
Isolated Gastrointestinal Symptoms Isolated Gastrointestinal Symptoms
Total Total of all reporting groups

Baseline Measures
    Short Stature     Poor Weight Gain (Failure-To-Thrive)     Isolated Gastrointestinal Symptoms     Total  
Number of Participants  
[units: participants]
  33     8     11     52  
Age  
[units: Years]
       
<=18 years     33     8     11     52  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Gender  
[units: Particpants]
       
Female     14     4     4     22  
Male     19     4     7     30  



  Outcome Measures
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1.  Primary:   Total Ghrelin Level   [ Time Frame: Will be measured with baseline screening labs at enrollment. ]

2.  Primary:   Acylated Ghrelin Level   [ Time Frame: Will be measured with baseline screening labs at enrollment. ]


  Serious Adverse Events


  Other Adverse Events


  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: Dr. Jordan Pinsker
Organization: Tripler Army Medical Center
phone: 808-433-6338
e-mail: jordan.pinsker@us.army.mil


Publications of Results:

Responsible Party: Jordan Pinsker, Tripler Army Medical Center
ClinicalTrials.gov Identifier: NCT01070173     History of Changes
Other Study ID Numbers: 5H08
Study First Received: February 12, 2010
Results First Received: December 8, 2012
Last Updated: January 15, 2013
Health Authority: United States: Federal Government