Diagnosing Adult Growth Hormone Deficiency

Growth Hormone Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018886
• Other study ID #: 203/2001 and 502/2002
• Status: Completed
• Phase: N/A
• First received: January 6, 2017
• Last updated: January 11, 2017
• Start date: May 2001
• Est. completion date: December 2008

Study information

• Verified date: January 2017
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: The ethical Committee of Helsinki University Hospital
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

Other:
• GHRH 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.

Locations

Country	Name	City	State
Finland	Tuula Pekkarinen	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak serum GH (ug/l) by Immulite 2000 Xpi		one year	No
Secondary	Serum insulin like growth hormone 1 (IGF-1) concentration		one year	No
Secondary	Basal serum GH (ug/l) by Immulite 2000 Xpi		one year	No