Growth and Asymmetric diMethylArginine

Growth Hormone Deficiency Clinical Trial

— GAMMA  

Official title:

Validation of the Dosage of Asymmetric Dimethylarginine (ADMA) Plasma in the Assessment of Endothelial Dysfunction During Growth Hormone Deficiency and Intrauterine Growth Retardation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03422081
• Other study ID #: 2012_61
• Secondary ID: 2013-A00830-45
• Status: Active, not recruiting
• Start date: June 2014
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 artery, at ultrasound examination, after the deflation of a cushion to evaluate artery dysfunction (vascular suffering) in growth diseases, growth hormone deficiency (GHD) and intrauterine growth retardation (IUGR)

Secondary objectives:

• Comparison of ADMA plasma concentrations with dose of matched healthy control children

• Investigation of the mechanisms of arterial dysfunction, inflammation, oxidative stress and insulin resistance.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency
• Small-for-gestational Age

Intervention

Diagnostic Test:
• arterial doppler ultrasound
doppler ultrasound

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandre - CHRU de Lille	Lille
France	CHU Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Asymmetric Dimethylarginine (ADMA)	Correlation between ADMA (Asymmetric DimethylArginine, a collateral derivate of nitric oxide metabolism) levels and the percentage of dilation of the brachial artery at Doppler ultrasound examination.; The dosage will be performed by high pressure liquid chromatography followed by tandem mass spectrometry (HPLC-MS / MS)	At baseline
Primary	Percentage of dilation of the brachial artery at Doppler ultrasound examination.	Correlation between ADMA (Asymmetric DimethylArginine, a collateral derivate of nitric oxide metabolism) levels and the percentage of dilation of the brachial artery at Doppler ultrasound examination.	At baseline.
Secondary	Difference of ADMA concentration between the patient and the control groups		At baseline
Secondary	Correlation of ADMA levels with diverse cardiovascular risk factors		At baseline