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Diagnosing Adult Growth Hormone Deficiency

Primary Purpose

Growth Hormone Deficiency

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
GHRH plus arginine test
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Growth Hormone Deficiency

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tuula Pekkarinen

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

healthy control subjects

patients with suspected GH deficiency

Arm Description

126 healthy controls underwent the GHRH plus arginine stimulations test

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

Outcomes

Primary Outcome Measures

Peak serum GH (ug/l) by Immulite 2000 Xpi

Secondary Outcome Measures

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

Full Information

First Posted
January 6, 2017
Last Updated
January 11, 2017
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03018886
Brief Title
Diagnosing Adult Growth Hormone Deficiency
Official Title
Diagnosis of Adult Growth Hormone Deficiency With Growth Hormone Releasing Hormone Plus Arginine Stimulation Test
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy control subjects
Arm Type
Other
Arm Description
126 healthy controls underwent the GHRH plus arginine stimulations test
Arm Title
patients with suspected GH deficiency
Arm Type
Experimental
Arm Description
34 patients with pituitary disease and suspicion of GH deficiency underwent the GHRH plus arginine test
Intervention Type
Other
Intervention Name(s)
GHRH plus arginine test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peak serum GH (ug/l) by Immulite 2000 Xpi
Time Frame
one year
Secondary Outcome Measure Information:
Title
Serum insulin like growth hormone 1 (IGF-1) concentration
Time Frame
one year
Title
Basal serum GH (ug/l) by Immulite 2000 Xpi
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: for health patients: age 20-60 years, no symptoms indicative of disease. for patients: age 16-90 years previous pituitary disease suspicion of growth hormone deficiency Exclusion Criteria: for healthy controls: pregnancy, a known or suspected disease, any symptoms indicating disease use of medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esa Hamalainen, MD, PhD
Organizational Affiliation
Chief, Department of Clinical Chemistry, Helsinki University Hospital, Helsinki, Finland
Official's Role
Study Director
Facility Information:
Facility Name
Tuula Pekkarinen
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

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Diagnosing Adult Growth Hormone Deficiency

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