Ghrelin Levels in Children With Poor Growth

NCT01070173 | Completed Results

• 1 other identifier: 5H08
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Short Stature; Failure to Thrive

Keywords

Ghrelin; short stature; failure to thrive

Outcome Measures

Primary Outcomes (2)

• Total Ghrelin Level

  Will be measured with baseline screening labs at enrollment.

• Acylated Ghrelin Level

  Will be measured with baseline screening labs at enrollment.

Study Arms (3)

Short Stature

Poor linear growth

Poor Weight Gain (Failure-To-Thrive)

Poor Weight Gain

Isolated Gastrointestinal Symptoms

No growth symptoms

Eligibility Criteria

• Age: 3 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Must not have a known diagnosis as an etiology for growth failure or GI symptoms prior to presentation.

Sponsors & Collaborators

• Tripler Army Medical Center: lead

Study Sites (1)

Tripler Army Medical Center/Dept of Pediatrics

Tripler AMC, Hawaii, 96859, United States

Location

Related 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.

  PMID: 21386753 RESULT

MeSH Terms

Conditions

Failure to Thrive; Dwarfism

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Jordan Pinsker
• Organization: Tripler Army Medical Center

jordan.pinsker@us.army.mil

808-433-6338

Study Officials

• Jordan Pinsker, MD

  Tripler Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Pediatric Endocrinology

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 17, 2010
• Study Start: January 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 18, 2013
• Results First Posted: February 18, 2013

Record last verified: 2013-01

Locations

US (1)