Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency

NCT01060488 | Completed Phase 3

• 1 other identifier: IMP24689
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency (AGHD) and subjects who were probably free of AGHD.

Conditions

Growth Hormone Deficiency

Keywords

GH secretion tests; adverse effects; adult growth hormone deficiency; growth-hormone releasing hormone and arginine test; insulin tolerance test; GHRH + Arginine test

Outcome Measures

Primary Outcomes (1)

• Level of GH peak (recorded following stimulation tests)

  within 120 min after stimulation (blood samples were tacken at T0(before), T15, T30, T45, T60, T90 and T120 min after stimulation).

Secondary Outcomes (1)

• It was asked to the patients to evaluate acceptability of each test via a visual analogic scale.

  After each test and before leaving the hospital (the day of the test)

Study Arms (2)

Group 1:

ACTIVE COMPARATOR

Other: GHRH+Arg, GHRH+Arg, ITT

Group 2:

ACTIVE COMPARATOR

Other: ITT, ITT, GHRH+Arg.

Interventions

GHRH+Arg, GHRH+Arg, ITT OTHER

GHRH+Arg repeatability test (2 tests) + comparison with one IT test

Group 1:

ITT, ITT, GHRH+Arg. OTHER

IT repeatability test (2 tests) + comparison with one GHRH+Arg test

Group 2:

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged over 18 years and under 60 years,
• Female or male,
• Subjects not treated by GH or having stopped the treatment more than 15 days ago,
• Effective contraception in women of childbearing age: hormonal contraception or use of female condom and spermicides or use of diaphragm and spermicides or Intra Uterine Device (IUD),
• Signed informed consent,
• Subjects possessing social security cover.
• Subjects having at least one of the following criteria were considered as subjects with a high probability of presenting a GH deficit:
• Subjects with a tumour of the hypothalamo-hypophyseal region (hypophyseal adenomata, craniopharyngioma, meningioma, etc.) in whom the presence of a hypophyseal insufficiency in GH must be tested preoperatively or postoperatively, or
• Subjects presenting a secondary ante-hypophyseal insufficiency to an inflammatory, infectious, post-traumatic pathology or to a hypophyseal necrosis, whose hypophyseal functional condition has already been documented and for whom a revaluation of GH secretion is desired, or
• Subjects having undergone, as adults, an irradiation hypothalamo-hypophyseal region, or a suprasellar irradiation, in a clinical context of GH deficit, or
• Subjects with a known organic ante-hypophyseal insufficiency beginning in childhood and with at least 1 associated deficit excluding prolactin.
• Subjects having at least one of the following criteria were considered as subjects with a low probability of presenting a GH deficit:
• Subjects with known idiopathic isolated GH deficit starting in childhood and for whom a new growth hormone secretion test is desired, or
• Subjects with non-operated microadenoma (\< 1 cm of diameter), or
• Subjects with fortuitously discovered intrasellar image (e.g. Rathke's pocket cyst).

You may not qualify if:

• Subjects presenting a coronary history or whose electrocardiographic signs evoke an ischemic pathology,
• Subjects presenting a history of cerebrovascular insufficiency,
• Subjects presenting a history of epilepsy,
• Subjects with an evolutive acromegalia or an evolutive Cushing's syndrome,
• Subjects presenting a known intolerance to arginine, GHRH or insulin,
• Hyperkalemic subjects,
• Diabetic subjects (Type 1 or Type 2),
• Very obese subjects (BMI \> 40),
• Subjects presenting a severe, hepatic, renal, tumoral evolutive affection or metabolic or respiratory acidosis,
• Subjects with known immuno-depression,
• Subjects with psychiatric disorders,
• Subjects presenting Parkinson's disease or Parkinsonian syndromes treated by Levodopa®,
• Subjects treated by drugs directly affecting the hypophyseal secretion of somatotrophin (e.g. clonidine, levodopa) or provoking the release of somatostatin, antimuscarinic agents (atropine),
• Subjects with untreated hypothyroidism or subjects treated by anti-thyroid synthesis drugs,
• Participation in another biomedical research programme less than 3 months previously,

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

CHU Bicêtre, Endocrinology and Reproductive Diseases Department

Le Kremlin-Bicêtre, France

Location

Related Publications (1)

• Chanson P, Cailleux-Bounacer A, Kuhn JM, Weryha G, Chabre O, Borson-Chazot F, Dubois S, Vincent-Dejean C, Brue T, Fedou C, Bresson JL, Demolis P, Souberbielle JC. Comparative validation of the growth hormone-releasing hormone and arginine test for the diagnosis of adult growth hormone deficiency using a growth hormone assay conforming to recent international recommendations. J Clin Endocrinol Metab. 2010 Aug;95(8):3684-92. doi: 10.1210/jc.2010-0295. Epub 2010 May 19.

  PMID: 20484474 RESULT

MeSH Terms

Conditions

Dwarfism, Pituitary

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

Study Officials

• Philippe Chanson, MD, Professor

  CHU Bicêtre, Endocrinology and Reproductive Diseases Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: February 2, 2010
• Study Start: January 1, 2004
• Primary Completion: November 1, 2005
• Last Updated: August 5, 2014

Record last verified: 2011-07

Locations

FR (1)