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Trials / Completed

CompletedNCT03018886

Diagnosing Adult Growth Hormone Deficiency

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
160 (actual)
Sponsor
Helsinki University Central Hospital · Academic / Other
Sex
All
Age
16 Years – 80 Years
Healthy volunteers
Accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
OTHERGHRH plus arginine testOne 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.

Timeline

Start date
2001-05-01
Primary completion
2008-12-01
Completion
2008-12-01
First posted
2017-01-12
Last updated
2017-01-12

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT03018886. Inclusion in this directory is not an endorsement.

Diagnosing Adult Growth Hormone Deficiency (NCT03018886) · Clinical Trials Directory