Diagnosing Adult Growth Hormone Deficiency

Overview

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 Title of Study: “Diagnosis of Adult Growth Hormone Deficiency With Growth Hormone Releasing Hormone Plus Arginine Stimulation Test”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2008

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

  • 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.

Arms, Groups and Cohorts

  • Other: healthy control subjects
    • 126 healthy controls underwent the GHRH plus arginine stimulations test
  • Experimental: patients with suspected GH deficiency
    • 34 patients with pituitary disease and suspicion of GH deficiency underwent the GHRH plus arginine test

Clinical Trial Outcome Measures

Primary Measures

  • Peak serum GH (ug/l) by Immulite 2000 Xpi
    • Time Frame: one year

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Helsinki University Central Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: tuula pekkarinen, consulting endocrinologist – Helsinki University Central Hospital
  • Overall Official(s)
    • Esa Hamalainen, MD, PhD, Study Director, Chief, Department of Clinical Chemistry, Helsinki University Hospital, Helsinki, Finland

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