Skip to main content
OpenTrials
Completed

NCT Number: NCT03018886

Diagnosing Adult Growth Hormone Deficiency

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuula Pekkarinen

Helsinki, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GHRH plus arginine test

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.

Primary outcomes

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

    Time frame: one year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2008
Study completion
2008
First posted
Jan 12, 2017
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.