Ghrelin Levels in Children With Poor Growth

NCT ID: NCT01070173

Last Updated: 2013-02-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Short Stature Failure to Thrive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Short Stature

Poor linear growth

No interventions assigned to this group

Poor Weight Gain (Failure-To-Thrive)

Poor Weight Gain

No interventions assigned to this group

Isolated Gastrointestinal Symptoms

No growth symptoms

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tripler Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Jordan Pinsker

Chief, Pediatric Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jordan Pinsker, MD

Role: PRINCIPAL_INVESTIGATOR

Tripler Army Medical Center

Locations

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Tripler Army Medical Center/Dept of Pediatrics

Tripler AMC, Hawaii, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21386753 (View on PubMed)

Other Identifiers

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5H08

Identifier Type: -

Identifier Source: org_study_id

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