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.
| ISRCTN | ISRCTN36070540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36070540 |
| Secondary identifying numbers | N0063072321 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 27/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof S M Shalet
Scientific
Scientific
Endocrinology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
| Phone | +44 (0)161 446 3667 |
|---|---|
| stephen.m.shalet@manchester.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | combination of GHRH (growth hormone releasing hormone) plus Arginine |
| Primary outcome measure | Primary end point: growth hormone response to different provocative tests. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 26/05/2000 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 30-40 patients from the Trust will be entered to this study. |
| Key inclusion criteria | Not provided at time of registration |
| Key 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 |
| Date of first enrolment | 26/05/2000 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Endocrinology
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Christie Hospital NHS Trust, Christie Endocrinology Department Research Fund (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2003 | Yes | No |
