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

August 4, 2014 updated by: Merck KGaA, Darmstadt, Germany

A Phase III, Multicentric, Open-label, Randomised, Comparative, Parallel Group Study of (GHRH + Arginine) Combination Test vs. Insulin Tolerance Test (ITT) in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The randomisation was carried out before the first test was performed. In order to be informed of the subject's randomisation group, the investigator phoned the access number given to him/her. The subject's allocation to a given randomisation arm was determined on the basis of a centralised randomisation (answering service), balanced per group of subjects with a minimisation on 2 criteria: age and BMI.

This was a centralised randomisation using a Interactive Voice Response System (IVRS) which was balanced in each of the following 3 categories of subjects:

  • Category A = healthy volunteers,
  • Category B = subjects with a strong probability of deficit in GH,
  • Category C = subjects with a low probability of deficit in GH.

In each of these 3 categories, the subjects underwent 3 tests whose sequences were determined by the following randomisation group:

  • Group 1: GHRH+Arg, GHRH+Arg, ITT or
  • Group 2: ITT, ITT, GHRH+Arg.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Kremlin Bicêtre, France
        • CHU Bicêtre, Endocrinology and Reproductive Diseases Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

The third category of subjects eligible was made of healthy volunteers.

Exclusion Criteria:

  • 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,
  • Known evolutive pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1:
Other: GHRH+Arg, GHRH+Arg, ITT
GHRH+Arg repeatability test (2 tests) + comparison with one IT test
Active Comparator: Group 2:
Other: ITT, ITT, GHRH+Arg.
IT repeatability test (2 tests) + comparison with one GHRH+Arg test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of GH peak (recorded following stimulation tests)
Time Frame: within 120 min after stimulation (blood samples were tacken at T0(before), T15, T30, T45, T60, T90 and T120 min after stimulation).
within 120 min after stimulation (blood samples were tacken at T0(before), T15, T30, T45, T60, T90 and T120 min after stimulation).

Secondary Outcome Measures

Outcome Measure
Time Frame
It was asked to the patients to evaluate acceptability of each test via a visual analogic scale.
Time Frame: After each test and before leaving the hospital (the day of the test)
After each test and before leaving the hospital (the day of the test)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Investigators

  • Principal Investigator: Philippe Chanson, MD, Professor, CHU Bicêtre, Endocrinology and Reproductive Diseases Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMP24689

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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