Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/11/2014
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 M Akber

ORCID ID

Contact details

North Staffs Hospital Trust
Ward 60
City General
Stoke-on-Trent
ST4 6QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0158124149

Study information

Scientific title

Dehydroepiandrosterone (DHEA) replacement in patients with secondary adrenal insufficiency (hypopituitarism)

Acronym

Study hypothesis

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.

Ethics approval

Not provided at time of registration

Study design

Double-blind placebo-controlled crossover study with a prearranged randomisation schedule

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Adrenal insufficiency

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

dehydroepiandrosterone (DHEA)

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2002

Overall trial end date

01/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2002

Recruitment end date

01/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Staffs Hospital Trust
Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

North Staffordshire Research and Development Consortium (UK)

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

Publication citations

Additional files

Editorial Notes