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ISRCTN
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ISRCTN93511659
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ClinicalTrials.gov identifier
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Public title
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Glucocorticoid replacement therapy and fibrinolysis.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0050153132
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Nutritional, Metabolic, Endocrine: Hypopituitarism
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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19/11/2004
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Anticipated end date
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01/04/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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15 patients and 10 controls will be recruited for the study.
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Interventions
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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).
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Primary outcome measure(s)
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Fibrinolytic parameter measurements.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Bradford Teaching Hospitals NHS Foundation Trust (UK) Own account but no NHS R&D Support Funding
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Trial website
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Publications
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2010 results presented at Society for Endocrinology BES 2010 in http://www.endocrine-abstracts.org/ea/0021/ea0021p261.htm
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Contact name
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Dr
Steve
Peacey
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Address
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Diabetes & Endocrinology
Bradford Royal Infirmary
Duckworth Lane
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City/town
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Bradford
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Zip/Postcode
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BD9 6RJ
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Country
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United Kingdom
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Tel
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+44 (0)1274 382019
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Email
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srpeacey@talk21.com
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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31/08/2010
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Date ISRCTN assigned
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30/09/2005
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