Diagnosing Adult Growth Hormone Deficiency

NCT ID: NCT03018886

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2008-12-31

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.

Conditions

Growth Hormone Deficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

healthy control subjects

126 healthy controls underwent the GHRH plus arginine stimulations test

Group Type: OTHER

GHRH plus arginine test

Intervention Type: OTHER

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.

patients with suspected GH deficiency

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

Group Type: EXPERIMENTAL

GHRH plus arginine test

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

tuula pekkarinen

consulting endocrinologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esa Hamalainen, MD, PhD

Role: STUDY_DIRECTOR

Chief, Department of Clinical Chemistry, Helsinki University Hospital, Helsinki, Finland

Locations

Tuula Pekkarinen

Helsinki, , Finland

Countries

Finland

Other Identifiers

203/2001 and 502/2002

Identifier Type: -

Identifier Source: org_study_id