Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000234819
Ethics application status
Approved
Date submitted
23/02/2012
Date registered
23/02/2012
Date last updated
23/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of steroids on blood sugar levels and risk of heart disease in pituitary patients
Scientific title
Effect of glucocorticoid replacement dose on cardiovascular risk and postprandial blood glucose in hypopituitary patients
Secondary ID [1] 280019 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary adrenal insufficiency 285928 0
Hypopituitarism 285935 0
Condition category
Condition code
Metabolic and Endocrine 286116 286116 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An open interventional study assessing the effect of increasing oral glucocorticoid dose on arterial stiffness, endothelial function and autonomic nervous system activity.

Subjects will be studied on their usual oral glucocorticoid dose and then again after increasing their oral glucocorticoid dose to hydrocortisone equivalent 30 mg/day for 7 days.

At each study visit, subjects will be studied before and after drinking an oral glucose load (75 g)
Intervention code [1] 284338 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286592 0
The primary endpoint is the change in pulse wave velocity with higher glucocorticoid dose, assessed by paired t-tests.
Timepoint [1] 286592 0
After increased glucocorticoid dose for 7 days
Secondary outcome [1] 296225 0
Changes in autonomic nervous system activity as reflected in baroreceptor sensitivity (slope), measured using the TaskForce Monitor (CNSystems)
Timepoint [1] 296225 0
After increased glucocorticoid dose for 7 days
Secondary outcome [2] 296226 0
Changes in endothelial function as reflected in Reactive Hyperaemia Index as calculated by the EndoPAT (Itamar Medical)
Timepoint [2] 296226 0
After increased glucocorticoid dose for 7 days
Secondary outcome [3] 296227 0
The correlation between changes in post-glucose load glucose concentration and insulin sensitivity and markers of cardiovascular risk.

Post-glucose load glucose concentration will be determined by blood test after an oral glucose load (75g). Insulin sensitivity will be estimated based on the insulin and glucose results during the oral glucose tolerance test. Markers of cardiovascular risk are as listed above (pulse wave velocity, autonomic nervous system function, endothelial function). Statistical correlation analysis will be performed on the results - the test used will depend on whether the results are parametric or non-parametric.
Timepoint [3] 296227 0
After increased glucocorticoid dose for 7 days

Eligibility
Key inclusion criteria
Hydrocortisone less than or equal to 20mg per day (or other glucocorticoid at equivalent dose)
GC use for at least 6 months
Age greater than or equal to 20 years
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Atrial fibrillation
Beta blocker medication
Raynaud’s phenomenon
Inability to provide written informed consent
On treatment for diabetes

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284771 0
Commercial sector/Industry
Name [1] 284771 0
Pfizer CVL Grant
Country [1] 284771 0
Australia
Funding source category [2] 284772 0
Charities/Societies/Foundations
Name [2] 284772 0
Flinders Medical Centre Foundation
Country [2] 284772 0
Australia
Primary sponsor type
Individual
Name
Dr Morton Burt
Address
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park
SA 5041
Country
Australia
Secondary sponsor category [1] 283662 0
Hospital
Name [1] 283662 0
Flinders Medical Centre
Address [1] 283662 0
Flinders Drive
Bedford Park
SA 5042
Country [1] 283662 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286765 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 286765 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Ethics committee country [1] 286765 0
Australia
Date submitted for ethics approval [1] 286765 0
Approval date [1] 286765 0
13/12/2010
Ethics approval number [1] 286765 0
1/10/0401

Summary
Brief summary
This study aims to assess whether higher doses of steroids increase the risk of heart disease in pituitary patients.

We hope that this study will increase the understanding of the effects of steroid replacement dose in patients with pituitary disorders. This information may influence what doses of steroid replacement are optimal for the long-term health of pituitary patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33827 0
Address 33827 0
Country 33827 0
Phone 33827 0
Fax 33827 0
Email 33827 0
Contact person for public queries
Name 17074 0
Dr Morton Burt
Address 17074 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park
SA 5041
Country 17074 0
Australia
Phone 17074 0
+61 8 8275 1094
Fax 17074 0
+61 8 8275 1215
Email 17074 0
morton.burt@health.sa.gov.au
Contact person for scientific queries
Name 8002 0
Dr Morton Burt
Address 8002 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park
SA 5041
Country 8002 0
Australia
Phone 8002 0
+61 8 8275 1094
Fax 8002 0
+61 8 8275 1215
Email 8002 0
morton.burt@health.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThrombospondin-1 is a glucocorticoid responsive protein in humans.2016https://dx.doi.org/10.1530/EJE-15-0964
N.B. These documents automatically identified may not have been verified by the study sponsor.