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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Page 1 of 1 (2 locations)

1

Hôpital Jeanne de Flandre - CHRU de Lille

Lille, France

2

CHU Purpan

Toulouse, France