Failure to Thrive, Idiopathic Short Stature
Conditions
Keywords
Ghrelin, short stature, failure to thrive
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.
Interventions
None listed
Sponsors
Tripler Army Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 21 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Ghrelin Level | Will be measured with baseline screening labs at enrollment. |
| Acylated Ghrelin Level | Will be measured with baseline screening labs at enrollment. |
Countries
United States
Participant flow
Recruitment details
Fifty-two patients were recruited into the study.
Participants by arm
| Arm | Count |
|---|---|
| Short Stature Poor linear growth | 33 |
| Poor Weight Gain (Failure-To-Thrive) Poor Weight Gain (Failure-To-Thrive) | 8 |
| Isolated Gastrointestinal Symptoms Isolated Gastrointestinal Symptoms | 11 |
| Total | 52 |
Baseline characteristics
| Characteristic | Short Stature | Poor Weight Gain (Failure-To-Thrive) | Isolated Gastrointestinal Symptoms | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 33 Participants | 8 Participants | 11 Participants | 52 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 14 Participants | 4 Participants | 4 Participants | 22 Participants |
| Sex: Female, Male Male | 19 Participants | 4 Participants | 7 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 8 | 0 / 11 |
| serious Total, serious adverse events | 0 / 33 | 0 / 8 | 0 / 11 |
Outcome results
Primary
Acylated Ghrelin Level
Time frame: Will be measured with baseline screening labs at enrollment.
Population: All participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Stature | Acylated Ghrelin Level | 190 pg/mL | Standard Deviation 34 |
| Poor Weight Gain (Failure-To-Thrive) | Acylated Ghrelin Level | 465 pg/mL | Standard Deviation 128 |
| Isolated Gastrointestinal Symptoms | Acylated Ghrelin Level | 176 pg/mL | Standard Deviation 37 |
Primary
Total Ghrelin Level
Time frame: Will be measured with baseline screening labs at enrollment.
Population: All participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Stature | Total Ghrelin Level | 1063 pg/mL | Standard Deviation 77 |
| Poor Weight Gain (Failure-To-Thrive) | Total Ghrelin Level | 1264 pg/mL | Standard Deviation 245 |
| Isolated Gastrointestinal Symptoms | Total Ghrelin Level | 1157 pg/mL | Standard Deviation 105 |