Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
31/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes