Status:
COMPLETED
Growth and Asymmetric diMethylArginine
Lead Sponsor:
University Hospital, Lille
Conditions:
Growth Hormone Deficiency
Small-for-gestational Age
Eligibility:
All Genders
3-18 years
Brief Summary
Principal objective : Validation of a handy biochemical parameter, plasma concentration of Asymmetric DimethylArginine (ADMA), based on a recognize biochemical parameter, the dilation of the brachial ...
Eligibility Criteria
Inclusion
- Group A: GHD, defined by 2 GH peaks less than 6.6 ng/ml (20 mU/L) at two stimulation tests
- Group B: IUGR, defined by a birth length and/or a birth weight inferior to - 2 SD for gestational age according to Usher and McLean charts
- Group C: Control children matched to children matched to subjects of groups A and B, according to gender and age
- Informed consent signed by representative of the parental authority
Exclusion
- Chronic disabling disease (ex: diabetes, severe asthma)
- Evolving cancer
- Severe psychiatric disorder (ex: autism, schizophrenia; severe depression)
- Hypothalamic tumor (ex: craniopharyngioma)
- Anamnesis of cranial irradiation
- Overweight, obesity or thinness
- Precocious puberty
- Non-replacing therapy by glucocorticoids or sex steroids less than 1 month before the exploration
- Anterior treatment by recombinant human GH
- Other conditions, treatments or habits impacting arterial reactivity: acrocyanosis, cryoglobulinemia, beta adrenergic blocking habits, tobacco smoking or other drug addictions, dyslipidemia
- Pregnancy or lactation
- Acute infection less than three weeks before the investigation
- Participation to a therapeutic protocol
- Impossibility for the representatives of the parental authority to understand the objectives of the protocol
- Absence of social security coverage. Refusal by the parents to sign the informed consent or oral refusal by the child to participate to the study
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03422081
Start Date
June 1 2014
End Date
December 31 2018
Last Update
December 16 2025
Active Locations (2)
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1
Hôpital Jeanne de Flandre - CHRU de Lille
Lille, France
2
CHU Purpan
Toulouse, France