Contact information
Type
Scientific
Primary contact
Dr Steve Peacey
ORCID ID
Contact details
Diabetes & Endocrinology
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 382019
srpeacey@talk21.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0050153132
Study information
Scientific title
Acronym
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
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
Phase
Not Specified
Drug names
Primary outcome measures
Fibrinolytic parameter measurements.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/11/2004
Overall trial end date
01/04/2007
Reason abandoned
Eligibility
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 type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
15 patients and 10 controls will be recruited for the study.
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
United Kingdom
Trial participating centre
Diabetes & Endocrinology
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bradford Teaching Hospitals NHS Foundation Trust (UK) Own account but no NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results presented at Society for Endocrinology BES 2010 in http://www.endocrine-abstracts.org/ea/0021/ea0021p261.htm