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ISRCTN
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ISRCTN14203656
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ClinicalTrials.gov identifier
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Public title
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Dehydroepiandrosterone (DHEA) replacement in patients with secondary adrenal insufficiency (hypopituitarism)
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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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N0158124149
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Study hypothesis
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To evaluate the benefits of dehydroepiandrosterone (DHEA) replacement in terms of improvement in quality of life as compared to placebo in patients with secondary adrenal insufficiency and to assess its influence on serum lipids, insulin resistance and endothelial function.
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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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Double blind placebo controlled crossover study with a prearranged randomisation schedule
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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: Adrenal insufficiency
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Participants - inclusion criteria
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1. 20 patients between the age of 20 and 60 years
2. With adrenal insufficiency secondary to panhypopituitarism of varying aetiology
3. Of at least one years duration enrolled from outpatient clinics of City General Hospital
4. They would be adequately replaced with regards to corticosteroid, thyroxine and sex steroid deficiency with unchanged replacement dose over the preceding 3 months
5. None of the patients would receive growth hormone replacement therapy
6. Patients with significant co-morbidity, those with hormone dependent conditions like breast cancer, pregnant women are excluded
7. Written consent would be obtained from all patients
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/12/2002
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Anticipated end date
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01/10/2003
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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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20
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Interventions
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For the first 4 months each patient would receive either 50 mg of DHEA administered orally or a placebo tablet of identical appearance. Following a washout period of one month the form of therapy would be switched and would be continued for a further period of 4 months.
Allocation details would only be known to an independent statistician and would remain coded until the trial is completed. Patients would be asked to attend the metabolic unit following overnight fast at 0, 4, 5 and 9 months. Pre-menopausal patients would be assessed during the follicular phase of the menstrual cycle. Any side effects would be noted and weight, body mass index (BMI) and blood pressure (BP). Quality of Life (QoL) Questionnaires would be completed and blood samples would be collected for biochemical and hormonal assays and biochemical markers of endothelial function. Short insulin tolerance test would be used as a measure of peripheral insulin sensitivity. After an overnight fast - 0.1 unit/kg body weight of soluble insulin would be injected at 0 minute and blood glucose would be measured at 0, 3, 6, 9, 12 and 15 minutes. The rate of fall of blood glucose, which indicates the endogenous glucose disposal rate, would be calculated from the linear regression of all values between 3 and 15 minutes and the rate of fall in percept per minute would be taken as an index of insulin sensitivity. In addition, biophysical markers of endothelial function would be measured by high resolution ultrasonography and would include carotid intima-media thickness and flow mediated dilatation of the brachial artery. For the latter, flow and diameter of the right brachial artery would be initially measured at rest. A tourniquet would be applied on the forearm and inflated to 250 mm of Hg for 5 minutes and the above measurements on the brachial artery would be repeated following the release of the tourniquet. The change in the diameter would be expressed as a percentage of the baseline diameter. Mean baseline values for each parameter would be compared to the mean post treatment values for placebo and for DHEA arms of the treatment and statistical significance would be assessed using the Student-t test or the Mann Whitney U test, depending on whether the variables are normally disrupted or not. 5% level of significance would be used.
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Primary outcome measure(s)
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1. Body mass index
2. Blood pressure (BP)
3. Quality of life (QoL) assessment
4. Hormone, Biochemical and Endothelial markers (detail give above)
5. Insulin tolerance test
6. Ultrasonographic assessment of endothelial function by checking carotid intima-media thickness
7. Flow mediated dilatation of the brachial artery
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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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North Staffordshire Research and Development Consortium (UK)
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Trial website
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Publications
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Contact name
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Dr
M
Akber
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Address
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North Staffs Hospital Trust
Ward 60
City General
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City/town
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Stoke-on-Trent
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Zip/Postcode
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ST4 6QG
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Country
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United Kingdom
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Tel
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+44 (0)1782 553424
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Fax
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+44 (0)1782 553427
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2004 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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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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30/09/2004
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Last edited
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07/01/2009
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Date ISRCTN assigned
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30/09/2004
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