Ghrelin Levels in Children With 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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Key information

Conditions

Idiopathic Short Stature Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Failure to Thrive Genetic Diseases, Inborn Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 month–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tripler Army Medical Center/Dept of Pediatrics

Tripler AMC, Hawaii, 96859, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Total Ghrelin Level

Time frame: Will be measured with baseline screening labs at enrollment.
Acylated Ghrelin Level

Time frame: Will be measured with baseline screening labs at enrollment.

Sponsors and collaborators

Lead sponsor

Tripler Army Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Feb 17, 2010
Registry last updated: Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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