Diagnosing Adult Growth Hormone Deficiency

January 11, 2017 updated by: tuula pekkarinen, Helsinki University Central Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Tuula Pekkarinen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 78 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: healthy control subjects
126 healthy controls underwent the GHRH plus arginine stimulations test
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.
Experimental: patients with suspected GH deficiency
34 patients with pituitary disease and suspicion of GH deficiency underwent the GHRH plus arginine test
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Esa Hamalainen, MD, PhD, Chief, Department of Clinical Chemistry, Helsinki University Hospital, Helsinki, Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 6, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 203/2001 and 502/2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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