An observational study in Idiopathic Short Stature and Failure to Thrive, sponsored by Tripler Army Medical Center. Completed at 1 site in United States. Open to participants aged 3 Months to 21 Years. Per ClinicalTrials.gov, last updated 2013-02-18.
Sponsored by Tripler Army Medical Center · Observational
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.
125 studies on the registry are indexed under Dwarfism; 19 are open to participants now.
This study's enrollment of 52 is below the median of 100 across 44 observational studies indexed under Dwarfism.
Browse Dwarfism studies →Tripler Army Medical Center is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Poor linear growth
Poor Weight Gain
No growth symptoms
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.
Fifty-two patients were recruited into the study.
| Milestone | Short Stature | Poor Weight Gain (Failure-To-Thrive) | Isolated Gastrointestinal Symptoms |
|---|---|---|---|
| Started | 33 | 8 | 11 |
| Completed | 33 | 8 | 11 |
| Not completed | 0 | 0 | 0 |
| pg/mL | Short Stature | Poor Weight Gain (Failure-To-Thrive) | Isolated Gastrointestinal Symptoms |
|---|---|---|---|
| Total Ghrelin Level | 1063 ± 77 | 1264 ± 245 | 1157 ± 105 |
| pg/mL | Short Stature | Poor Weight Gain (Failure-To-Thrive) | Isolated Gastrointestinal Symptoms |
|---|---|---|---|
| Acylated Ghrelin Level | 190 ± 34 | 465 ± 128 | 176 ± 37 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Short Stature | — | 0/33 (0%) | 0/33 (0%) |
| Poor Weight Gain (Failure-To-Thrive) | — | 0/8 (0%) | 0/8 (0%) |
| Isolated Gastrointestinal Symptoms | — | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Short Stature | Poor Weight Gain (Failure-To-Thrive) | Isolated Gastrointestinal Symptoms | Total |
|---|---|---|---|---|
| <=18 years | 33 | 8 | 11 | 52 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Short Stature | Poor Weight Gain (Failure-To-Thrive) | Isolated Gastrointestinal Symptoms | Total |
|---|---|---|---|---|
| Female | 14 | 4 | 4 | 22 |
| Male | 19 | 4 | 7 | 30 |
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Tripler Army Medical Center