Diagnosing Adult Growth Hormone Deficiency

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03018886

Enrollment

160

Registered

2017-01-12

Start date

2001-05-31

Completion date

2008-12-31

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

Brief 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.

Interventions

OTHERGHRH plus arginine test

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

for health patients: 1. age 20-60 years, 2. no symptoms indicative of disease. for patients: 1. age 16-90 years 2. previous pituitary disease 3. suspicion of growth hormone deficiency

Exclusion criteria

for healthy controls: 1. pregnancy, 2. a known or suspected disease, 3. any symptoms indicating disease 4. use of medication

Design outcomes

Primary

Measure	Time frame
Peak serum GH (ug/l) by Immulite 2000 Xpi	one year

Secondary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026