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

NCT ID: NCT02424240

Last Updated: 2015-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diagnosis of GHD With IGF-I/IGFBP-3 Ratio

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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IGF-I/ IGFBP-3 ratio group

IGF-1/IGFBP-3 ratio

Intervention Type OTHER

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

IGF-1 and IGFBP-3

No interventions assigned to this group

Interventions

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IGF-1/IGFBP-3 ratio

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Ayman Zayed, M.D., MSc, FACE, FACP

Ayman Zayed

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Endo-Ayman-789

Identifier Type: -

Identifier Source: org_study_id

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