| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN36070540 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0063072321 |
| Public title | A comparison between the Insulin Tolerance Test (ITT) and the combined growth Hormone Releasing Hormone and Arginine test to determine Growth Hormone (GH) status in cranially irradiated patients. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nutritional, Metabolic, Endocrine: Growth hormone deficiency |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 30-40 patients from the trust will be entered to this study. |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 26/05/2000 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Ongoing |
| Target number of participants | 30-40 patients |
| Interventions | 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) |
| Primary outcome measure(s) | Primary End Point: Growth Hormone response to different provocative tests. |
| Secondary outcome measure(s) | See Primary outcome measures |
| Sources of funding | Christie Hospital NHS Trust
Christie Endocrinology Department Research Fund
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof S M Shalet |
| Contact details | Endocrinology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
United Kingdom
M20 4BX |
| Contact telephone | +44 (0)161 446 3667 |
| Contact fax | +44 (0)161 446 3772 |
| Contact email | stephen.m.shalet@manchester.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN36070540 |
| Date last extracted from ISRCTN register | 17/04/2008 |
