Glucocorticoid replacement therapy and fibrinolysis.
| ISRCTN | ISRCTN93511659 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93511659 |
| Secondary identifying numbers | N0050153132 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 31/08/2010
- 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
Not provided at time of registration
Contact information
Dr Steve Peacey
Scientific
Scientific
Diabetes & Endocrinology
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
| Phone | +44 (0)1274 382019 |
|---|---|
| srpeacey@talk21.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | To determine whether the dose of adrenal steroid replacement therapy in patients with pituitary disease, influences the fibrinolytic system (clot breakdown system) and determine whether patients who receive higher adrenal steroid replacement dose are at greater risk of cardiovascular disease. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Nutritional, Metabolic, Endocrine: Hypopituitarism |
| Intervention | The study will be of randomised, open-label, crossover design, comparing the effects of traditional glucocorticoid replacement regimens versus modern regimens on fibrinolytic parameters in patients with hypopituitarism. Patients will have a two week period of treatment with either their current 'optimised' treatment regimen or with a higher dose (approx 30 - 50%) traditional type regimen. At the end of each two week period they will be admitted to a day case ward for hourly blood sampling over a 10 hour period. Blood will be taken for cortisol levels (adrenal steroid) in a standard fashion ( a cortisol day profile) and for fibrinolytic parameters (i.e twice in total). |
| Intervention type | Other |
| Primary outcome measure | Fibrinolytic parameter measurements. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 19/11/2004 |
| Overall study end date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 15 patients and 10 controls will be recruited for the study. |
| Participant inclusion criteria | All patients over 18 years with documented adult hypopituitarism with proven ACTH deficiency, currently under follow up in the Bradford Teaching Hospitals NHS Trust, who have provided informed consent will be potentially eligible to participate in the study. Patients will be recruited from either direct contact in OPD or via direct phone contact with an endocrine specialist nurse. |
| Participant exclusion criteria | 1. Subjects requiring systematic steroid therapy 2. Subjects taking HRT or oral contraceptive 3. Subjects who are currently pregnant or who had recent pregnancy or abortion 4. Subjects with known malignancy 5. Subjects with known coagulopathy 6. Subjects who are currently taking or have recently taken anticoagulant therapy |
| Recruitment start date | 19/11/2004 |
| Recruitment end date | 01/04/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Diabetes & Endocrinology
Bradford
BD9 6RJ
United Kingdom
BD9 6RJ
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
Bradford Teaching Hospitals NHS Foundation Trust (UK) Own account but no 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? |
|---|---|---|---|---|---|
| Abstract results | results presented at Society for Endocrinology BES | 06/11/2010 | No | No |
