Diagnosing Adult Growth Hormone Deficiency

Not Applicable

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Other: GHRH plus arginine test

• Registration Number: NCT03018886
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2001-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-11
• Last Update Submitted: 2017-01-11
• Study First Posted: 2017-01-12
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy control subjects	GHRH plus arginine test	126 healthy controls underwent the GHRH plus arginine stimulations test
patients with suspected GH deficiency	GHRH plus arginine test	34 patients with pituitary disease and suspicion of GH deficiency underwent the GHRH plus arginine test

Primary Outcome Measures

Name	Time	Method
Peak serum GH (ug/l) by Immulite 2000 Xpi	one year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tuula Pekkarinen; 🇫🇮 Helsinki, Finland