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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

February 12, 2010
January 15, 2013
January 2008
September 2010   (final data collection date for primary outcome measure)
  • Total Ghrelin Level [ Time Frame: Will be measured with baseline screening labs at enrollment. ] [ Designated as safety issue: No ]
  • Acylated Ghrelin Level [ Time Frame: Will be measured with baseline screening labs at enrollment. ] [ Designated as safety issue: No ]
  • Total Ghrelin Level [ Time Frame: Will be measured with baseline screening labs at enrollment. If a treatable cause of poor growth is discovered, ghrelin will be remeasured 6 months after treatment is initiated and compared to baseline. ] [ Designated as safety issue: No ]
  • Acylated Ghrelin Level [ Time Frame: Will be measured with baseline screening labs at enrollment. If a treatable cause of poor growth is discovered, ghrelin will be remeasured 6 months after treatment is initiated and compared to baseline. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01070173 on ClinicalTrials.gov Archive Site
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Ghrelin Levels in Children With Poor Growth
Ghrelin Levels in Children With Gastrointestinal Symptoms and/or Poor Growth

The investigators hypothesize that low serum ghrelin levels may characterize a group of patients with poor weight gain and/or linear growth who do not have any other identified cause for growth failure. These patients may present with a variety of complaints and are often evaluated by both pediatric endocrinologists and pediatric gastroenterologists. The investigators hypothesize that ghrelin has a physiologically important role in linear growth and that chronic diseases of the gastrointestinal system, such as H. Pylori infection or celiac disease, may alter serum ghrelin levels in children. Low ghrelin levels may be a factor leading to poor growth, potentially by altering growth hormone secretion and/or by decreasing appetite. By measuring ghrelin levels in children with short stature and in children with gastrointestinal disease, the investigators will further elucidate the possible physiologic role of ghrelin in childhood growth and how it may be altered in conditions causing short stature and in certain gastrointestinal diseases.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Twenty-five (25) patients seen for evaluation of short stature in the pediatric endocrinology clinic will have serum ghrelin levels measured in addition to their usual routine bloods tests.

Twenty-five (25) patients will be selected from patients who present with chronic gastrointestinal symptoms (symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms) and who have poor growth.

The remaining 25 will be selected from patients with chronic gastrointestinal symptoms (symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms) who have normal growth.

  • Idiopathic Short Stature
  • Failure to Thrive
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  • Short Stature
    Poor linear growth
  • Poor Weight Gain (Failure-To-Thrive)
    Poor Weight Gain
  • Isolated Gastrointestinal Symptoms
    No growth symptoms
Pinsker JE, Ondrasik D, Chan D, Fredericks GJ, Tabisola-Nuesca E, Fernandez-Aponte M, Focht DR, Poth M. Total and acylated ghrelin levels in children with poor growth. Pediatr Res. 2011 Jun;69(6):517-21. doi: 10.1203/PDR.0b013e3182181b2c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • To be included in the short stature group, subjects must have had short stature, defined height less than -2 SD for gender and age or an abnormal growth velocity for gender and age).
  • To be included in the failure-to-thrive group, subjects must have had poor weight gain, defined as weight less than -2 SD for gender and age or an abnormal weight velocity for gender and age.
  • Patients in both groups will be evaluated for the presence of chronic gastrointestinal symptoms, defined as symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms. Patients who were affected in both weight and height will be stratified by which measurement was more severely affected, with poor weight gain being the primary problem in the "failure-to-thrive" grouping (Group 2) and "poor linear growth" being the primary problem in the short stature group (Group 1).
  • Patients who have had chronic gastrointestinal symptoms, defined as symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms, but normal stature and growth, will be analyzed separately (Group 3).

Exclusion Criteria:

  • Must not have a known diagnosis as an etiology for growth failure or GI symptoms prior to presentation.
Both
3 Months to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01070173
5H08
No
Jordan Pinsker, Tripler Army Medical Center
Tripler Army Medical Center
Not Provided
Principal Investigator: Jordan Pinsker, MD Tripler Army Medical Center
Tripler Army Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP