Diagnosing Adult Growth Hormone Deficiency

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Growth Hormone Deficiency

Treatments: Other: GHRH plus arginine test

Study type: Interventional

Funder types: Other

Identifiers

NCT03018886

203/2001 and 502/2002

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

healthy control subjects

Other group

Description:

126 healthy controls underwent the GHRH plus arginine stimulations test

Treatment:

Other: GHRH plus arginine test

patients with suspected GH deficiency

Experimental group

Description:

34 patients with pituitary disease and suspicion of GH deficiency underwent the GHRH plus arginine test

Treatment:

Other: GHRH plus arginine test