Status of Growth Hormone/ Insulin-like Growth Factor-1 (GH/IGF-1) Axis and Growth Failure in Atax… (NCT01052623) | Clinical Trial Compass
UnknownPhase 4
Status of Growth Hormone/ Insulin-like Growth Factor-1 (GH/IGF-1) Axis and Growth Failure in Ataxia Telangiectasia (AT)
Germany24 participantsStarted 2010-01
Plain-language summary
This study will evaluate the status of the growth hormone/ insulin-like growth factor-1 (GH/IGF-1) axis in relation to growth failure, body weight and composition and neuroprotection in children with Ataxia telangiectasia (AT).
Who can participate
Age range3 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a diagnosis of AT
* Have no fusion of epiphyses/closed growth plates as determined by X-ray of left wrist and hand (special skeletal age film)
* Be between 3 years to 18 years old and have not completed puberty
* Consent to permit blood and/or tissue samples for storage
* Demonstrate growth failure: height below the 10th percentile for chronological age
* Have a primary care physician at home
* Demonstrate growth failure, defined as growth velocity (measured as linear growth) that is less than 5% to 10% of that expected for children of the same age group, over the past 12 months
* Willingness to remain hospitalized for several days
* Provide evidence of serum IGF-1 level performed within the preceding 6 months and the results fall below 25% range of normal limits for age
Exclusion Criteria:
* Have fusion of epiphyseal plates
* Be under the age of 3 years or have reached completion of puberty
* Have a serum IGF-1 level that is above the 25% range of normal limits for age
* Be above the 10th percentile height for chronological age
* Demonstrate any history of anaphylactic reaction or hypersensitivity to one of the GH formulation
* Have any active or suspected neoplasia
* Demonstrate signs of intracranial hypertension as evidenced by papilledema upon examination by fundoscopy
* Have any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study
* Be unwilling to undergo testing or procedures associa…
What they're measuring
1
To evaluate the GH increase after Arginine Provocation Test
Timeframe: at minute 0, 30, 60, 90 und 120 after infusion