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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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
-
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.