Ghrelin Levels in Children With Poor Growth

Idiopathic Short Stature Clinical Trial

Official title:

Ghrelin Levels in Children With Gastrointestinal Symptoms and/or Poor Growth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070173
• Other study ID #: 5H08
• Status: Completed
• Phase: N/A
• First received: February 12, 2010
• Last updated: January 15, 2013
• Start date: January 2008
• Est. completion date: September 2010

Study information

• Verified date: January 2013
• Source: Tripler Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 21 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarfism
• Failure to Thrive
• Idiopathic Short Stature

Locations

Country	Name	City	State
United States	Tripler Army Medical Center/Dept of Pediatrics	Tripler AMC	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Tripler Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Ghrelin Level		Will be measured with baseline screening labs at enrollment.	No
Primary	Acylated Ghrelin Level		Will be measured with baseline screening labs at enrollment.	No