Ghrelin Levels in Children With Poor Growth - Full Text View

Sponsor:	Tripler Army Medical Center
Information provided by:	Tripler Army Medical Center
ClinicalTrials.gov Identifier:	NCT01070173

Purpose

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.

Condition
Idiopathic Short Stature Failure to Thrive

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Ghrelin Levels in Children With Gastrointestinal Symptoms and/or Poor Growth

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

MedlinePlus related topics: Dwarfism

Drug Information available for: Ghrelin

U.S. FDA Resources

Further study details as provided by Tripler Army Medical Center:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	75
Study Start Date:	January 2008
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Short Stature Poor linear growth
Poor Weight Gain (Failure-To-Thrive) Poor Weight Gain
Isolated Gastrointestinal Symptoms No growth symptoms

Eligibility

Ages Eligible for Study:	3 Months to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070173

Locations

United States, Hawaii
Tripler Army Medical Center/Dept of Pediatrics
Tripler AMC, Hawaii, United States, 96859

Sponsors and Collaborators

Tripler Army Medical Center

More Information

Publications:

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.

Responsible Party:	Jordan Pinsker, MD, Tripler Army Medical Center
ClinicalTrials.gov Identifier:	NCT01070173 History of Changes
Other Study ID Numbers:	5H08
Study First Received:	February 12, 2010
Last Updated:	June 6, 2011
Health Authority:	United States: Federal Government

Keywords provided by Tripler Army Medical Center:

Ghrelin
short stature
failure to thrive

Additional relevant MeSH terms:

Dwarfism
Failure to Thrive
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases

Genetic Diseases, Inborn
Endocrine System Diseases
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012