Growth and Asymmetric diMethylArginine

NCT03422081 | Completed

• 2 other identifiers: 2012_612013-A00830-45
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Growth Hormone Deficiency; Small-for-gestational Age

Keywords

endothelial dysfunction; doppler ultrasound examination; nitric oxide

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Difference of ADMA concentration between the patient and the control groups

  At baseline

• Correlation of ADMA levels with diverse cardiovascular risk factors

  At baseline

Study Arms (3)

growth hormone deficiency

Diagnostic Test: arterial doppler ultrasound

small for gestational age

Diagnostic Test: arterial doppler ultrasound

matched controls

Diagnostic Test: arterial doppler ultrasound

Interventions

arterial doppler ultrasound DIAGNOSTIC_TEST

doppler ultrasound

growth hormone deficiency; matched controls; small for gestational age

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pediatric patients with growth disorders and matched control children

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (2)

Hôpital Jeanne de Flandre - CHRU de Lille

Lille, France

Location

CHU Purpan

Toulouse, France

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Jacques Weill, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: February 5, 2018
• Study Start: June 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)