Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
27/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof S M Shalet

ORCID ID

Contact details

Endocrinology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
+44 (0)161 446 3667
stephen.m.shalet@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0063072321

Study information

Scientific title

Acronym

Study hypothesis

We aim to study the pattern of growth hormone response to a combination of GHRH (growth hormone releasing hormone) plus Arginine in adults with radiation induced growth hormone deficiency, to find out whether this stimulation test can successfully replace the Insulin Tolerance Test (ITT) for the diagnosis of radiation-induced growth hormone.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Growth hormone deficiency

Intervention

Patients will be reviewed in Endocrine Clinic. Those who fulfil the inclusion criteria will be invited to participate. An information sheet will provide full details of the study and what is involved. It is established practice that patients sign an informed consent before undergoing GH tests. Patients will undergo the ITT and GHRH+ARG. Stimulation tests in random order, at least three days apart. After overnight fasting, the patient will be admitted to the endocrine unit at 08:30h. A cannula will be inserted into a forearm vein and kept patent by normal saline. For the ITT, a bolus of 0.1u/kgregular insulin (actrapid) will be given intravenously and the blood glucose level measured (by glucometer) every 15 min. The patient will not be left unattended until the test is finished and the blood glucose level has returned to normal.
For the GHRH+Arginine test, a bolus of 1ug/kg GHRH24 will be infused over 30 min, from 0 to 30 min. Blood samples will be taken every 15 min from -15 to 120 min. They will be assayed for GH, IGF-I, IGFBP3 and Acid Labile sub-unit (ALS).

Intervention type

Drug

Phase

Not Specified

Drug names

combination of GHRH (growth hormone releasing hormone) plus Arginine

Primary outcome measures

Primary end point: growth hormone response to different provocative tests.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

26/05/2000

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

30-40 patients from the Trust will be entered to this study.

Participant exclusion criteria

1. Patients with pituitary tumours or previous surgery in the hypothalamic-pituitary field (non radiation-induced damage)
2. Patients with active or uncured malignancy
3. Patients who are suffering from any condition or disease or taking any medication that might affect the function of the hypothalamic-pituitary axis or interfere with the interpretation of the tests
4. Failure to sign an informed consent

Recruitment start date

26/05/2000

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Endocrinology
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Christie Hospital NHS Trust, Christie Endocrinology Department Research Fund (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12519836

Publication citations

  1. Results

    Darzy KH, Aimaretti G, Wieringa G, Gattamaneni HR, Ghigo E, Shalet SM, The usefulness of the combined growth hormone (GH)-releasing hormone and arginine stimulation test in the diagnosis of radiation-induced GH deficiency is dependent on the post-irradiation time interval., J. Clin. Endocrinol. Metab., 2003, 88, 1, 95-102, doi: 10.1210/jc.2002-021094.

Additional files

Editorial Notes