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Diagnosing Adult Growth Hormone Deficiency

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ClinicalTrials.gov Identifier: NCT03018886
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
tuula pekkarinen, Helsinki University Central Hospital

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

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Other: GHRH plus arginine test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosis of Adult Growth Hormone Deficiency With Growth Hormone Releasing Hormone Plus Arginine Stimulation Test
Study Start Date : May 2001
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Peak serum GH (ug/l) by Immulite 2000 Xpi [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Serum insulin like growth hormone 1 (IGF-1) concentration [ Time Frame: one year ]
  2. Basal serum GH (ug/l) by Immulite 2000 Xpi [ Time Frame: one year ]


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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018886


Locations
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Finland
Tuula Pekkarinen
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Study Director: Esa Hamalainen, MD, PhD Chief, Department of Clinical Chemistry, Helsinki University Hospital, Helsinki, Finland
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Responsible Party: tuula pekkarinen, consulting endocrinologist, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03018886    
Other Study ID Numbers: 203/2001 and 502/2002
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases