Diagnosing Adult Growth Hormone Deficiency

Study Overview
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Brief Summary
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The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against the IS 98/574 from the World Health Organization. A specific aim was to study the effect of gender and age on the peak GH response in the GHRH+arg test

Detailed Description
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Adult growth hormone deficiency (AGHD) is a clinical entity including increased abdominal fat mass, decreased muscle mass, low bone density and adverse effects on quality of life and cardiovascular morbidity. These signs are nonspecific, and accurate diagnosis with laboratory tests in needed. The GHRH+arg test is used to diagnose AGHD, but the cut-off values vary based on controls used. At moment consensus cut-off criteria are BMI specific, but gender and age may also affect the GH response in the GHRH+arg.

Official Title
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Diagnosis of Adult Growth Hormone Deficiency With Growth Hormone Releasing Hormone Plus Arginine Stimulation Test

Conditions
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Growth Hormone Deficiency

Intervention / Treatment
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* Other: GHRH plus arginine test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: for health patients: age 20-60 years, no symptoms indicative of disease. for patients: age 16-90 years previous pituitary disease suspicion of growth hormone deficiency Exclusion Criteria: for healthy controls: pregnancy, a known or suspected disease, any symptoms indicating disease use of medication

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: healthy control subjects<br>126 healthy controls underwent the GHRH plus arginine stimulations test | Other: GHRH plus arginine test<br>* One ug/kg GHRH [GHRH(1-29), GEREF Serono, Italy] was administered as an iv bolus at time 0 min, followed by arginine (L-arginine monohydrochloride, Braun, Melsungen, Germany) 0.5 g/kg (max 30g9 over 30 min. Blood samples were drawn at -15,0,15,30,45,60,75,90 min.<br>|
| Experimental: patients with suspected GH deficiency<br>34 patients with pituitary disease and suspicion of GH deficiency underwent the GHRH plus arginine test | Other: GHRH plus arginine test<br>* One ug/kg GHRH [GHRH(1-29), GEREF Serono, Italy] was administered as an iv bolus at time 0 min, followed by arginine (L-arginine monohydrochloride, Braun, Melsungen, Germany) 0.5 g/kg (max 30g9 over 30 min. Blood samples were drawn at -15,0,15,30,45,60,75,90 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak serum GH (ug/l) by Immulite 2000 Xpi |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum insulin like growth hormone 1 (IGF-1) concentration |  | one year | 
| Basal serum GH (ug/l) by Immulite 2000 Xpi |  | one year |