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OpenTrials
Completed

NCT Number: NCT02424240

Growth Hormone (GH) Deficiency & Insulin Like Growth Factor 1 (IGF-I)/ Insulin Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio

A 35-month cross-sectional observational study was conducted at an outpatient university hospital in Amman, Jordan. We obtained a comprehensive medical and laboratory evaluation for 134 short-statured children (64 boys and 70 girls, aged 4-16 years). Complete and partial growth hormone deficincy (GHD) were defined as peak forwth hormone (GH) response of 5 and 7 ng/ml [IRMA/ DiaSorin®], respectively in both clonidine stimulation and insulin tolerance tests. Serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 ratio were determined for all participants.

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Key information

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children presented to Jordan Univeristy Hospital (JUH) outpatient endocrinology clinic for the evaluation of short stature (SS)

Exclusion criteria

(i) their parents could not provide written consent for them; (ii) they were lost to follow up; (iii) they could not perform clonidine stimulation tests (CST) or insulin tolerance test (ITT) due to a medical contraindication (e.g. cardiac disorder, seizure disorder); (iv) they had received GH therapy in the past; (v) they were known to have pituitary diseases, hypothyroidism, hypogonadism or discovered to have panhypopituitarism or (vi) they have malnutrition, diabetes mellitus, liver disease, or other chronic illnesses.

Treatment and study plan

IGF-1/IGFBP-3 ratio

Other

IGF-1/IGFBP-3 ratio for the diagnosis of GHD Vs. IGF-1, IGFBP-3 and IGF-1 & IGFBP-3 combination

Primary outcomes

  1. Serum IGF-1/IGFBP-3 ratio

    Time frame: 33 months

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

The Emerging Role of Serum IGF-I/IGFBP-3 Ratio in the Diagnosis of Children With Growth Hormone Deficiency

Important dates

Study start
2011
Primary completion
2014
First posted
Apr 22, 2015
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.