Ghrelin Levels in Children With Poor Growth

• Sponsor: Tripler Army Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01070173
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Duration (Months): 32
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Short Stature; Failure to Thrive

Study Design

• Study Type: Observational
• Actual Enrollment: 52 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Ghrelin Levels in Children With Gastrointestinal Symptoms and/or Poor Growth
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Short Stature Poor linear growth
Poor Weight Gain (Failure-To-Thrive) Poor Weight Gain
Isolated Gastrointestinal Symptoms No growth symptoms

Outcome Measures

Primary Outcome Measures

1. Total Ghrelin Level [Will be measured with baseline screening labs at enrollment.]

2. Acylated Ghrelin Level [Will be measured with baseline screening labs at enrollment.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Tripler Army Medical Center/Dept of Pediatrics	Tripler AMC	Hawaii	United States	96859

Sponsors and Collaborators

• Tripler Army Medical Center

Investigators

• Principal Investigator: Jordan Pinsker, MD, Tripler Army Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jordan Pinsker, Chief, Pediatric Endocrinology, Tripler Army Medical Center
• ClinicalTrials.gov Identifier: NCT01070173
• Other Study ID Numbers: 5H08
• First Posted: Feb 17, 2010
• Last Update Posted: Feb 18, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Jordan Pinsker, Chief, Pediatric Endocrinology, Tripler Army Medical Center: Ghrelin; short stature; failure to thrive
• Additional relevant MeSH terms: Dwarfism; Failure to Thrive

Study Results

Participant Flow

Recruitment Details	Fifty-two patients were recruited into the study.

Arm/Group Title	Short Stature	Poor Weight Gain (Failure-To-Thrive)	Isolated Gastrointestinal Symptoms
Arm/Group Description	Poor linear growth Group	Poor Weight Gain (Failure-To-Thrive) Group	Isolated Gastrointestinal Symptoms Group
Period Title: Overall Study
STARTED	33	8	11
COMPLETED	33	8	11
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Short Stature	Poor Weight Gain (Failure-To-Thrive)	Isolated Gastrointestinal Symptoms	Total
Arm/Group Description	Poor linear growth	Poor Weight Gain (Failure-To-Thrive)	Isolated Gastrointestinal Symptoms	Total of all reporting groups
Overall Participants	33	8	11	52
Age (Count of Participants)
<=18 years	33 100%	8 100%	11 100%	52 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	14 42.4%	4 50%	4 36.4%	22 42.3%
Male	19 57.6%	4 50%	7 63.6%	30 57.7%

Outcome Measures

1. Primary Outcome

Title	Total Ghrelin Level
Time Frame	Will be measured with baseline screening labs at enrollment.

Outcome Measure Data

Analysis Population Description

All participants.

Arm/Group Title	Short Stature	Poor Weight Gain (Failure-To-Thrive)	Isolated Gastrointestinal Symptoms
Arm/Group Description	Poor linear growth Group	Poor Weight Gain (Failure-To-Thrive) Group	Isolated Gastrointestinal Symptoms Group
Measure Participants	33	8	11
Mean (Standard Deviation) [pg/mL]	1063 (77)	1264 (245)	1157 (105)

2. Primary Outcome

Title	Acylated Ghrelin Level
Time Frame	Will be measured with baseline screening labs at enrollment.

Outcome Measure Data

Analysis Population Description

All participants.

Arm/Group Title	Short Stature	Poor Weight Gain (Failure-To-Thrive)	Isolated Gastrointestinal Symptoms
Arm/Group Description	Poor linear growth Group	Poor Weight Gain (Failure-To-Thrive) Group	Isolated Gastrointestinal Symptoms Group
Measure Participants	33	8	11
Mean (Standard Deviation) [pg/mL]	190 (34)	465 (128)	176 (37)

Adverse Events

Arm/Group Title	Short Stature		Poor Weight Gain (Failure-To-Thrive)		Isolated Gastrointestinal Symptoms
Arm/Group Description	Poor linear growth Group		Poor Weight Gain (Failure-To-Thrive) Group		Isolated Gastrointestinal Symptoms Group
All Cause Mortality
	Short Stature		Poor Weight Gain (Failure-To-Thrive)		Isolated Gastrointestinal Symptoms
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Short Stature		Poor Weight Gain (Failure-To-Thrive)		Isolated Gastrointestinal Symptoms
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/8 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Short Stature		Poor Weight Gain (Failure-To-Thrive)		Isolated Gastrointestinal Symptoms
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/8 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.