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 of protocol

Not provided at time of registration

Contact information

Dr Steve Peacey
Scientific

Diabetes & Endocrinology
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone	+44 (0)1274 382019
Email	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 objectives	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
Health condition(s) or problem(s) studied	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
Completion 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.
Key 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.
Key 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
Date of first enrolment	19/11/2004
Date of final enrolment	01/04/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Diabetes & Endocrinology

Bradford
BD9 6RJ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	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