Diagnosing Adult Growth Hormone Deficiency

NCT03018886 | Completed

• 1 other identifier: 203/2001 and 502/2002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (2)

• Serum insulin like growth hormone 1 (IGF-1) concentration

  one year

• Basal serum GH (ug/l) by Immulite 2000 Xpi

  one year

Study Arms (2)

healthy control subjects

OTHER

126 healthy controls underwent the GHRH plus arginine stimulations test

Other: GHRH plus arginine test

patients with suspected GH deficiency

EXPERIMENTAL

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

Other: GHRH plus arginine test

Interventions

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.

healthy control subjects; patients with suspected GH deficiency

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• for healthy controls:
• pregnancy,
• a known or suspected disease,
• any symptoms indicating disease
• use of medication

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Tuula Pekkarinen

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Arginine

Condition Hierarchy (Ancestors)

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; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Esa Hamalainen, MD, PhD

  Chief, Department of Clinical Chemistry, Helsinki University Hospital, Helsinki, Finland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consulting endocrinologist

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 12, 2017
• Study Start: May 1, 2001
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

FI (1)