Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000540819
Ethics application status
Approved
Date submitted
16/05/2012
Date registered
22/05/2012
Date last updated
22/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of low dose steroids on blood glucose and risk of heart disease
Scientific title
Effect of therapeutic glucocorticoids on insulin sensitivity, cardiovascular risk and energy metabolism in patients with inflammatory arthritis
Secondary ID [1] 280489 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin sensitivity 286469 0
cardiovascular risk 286470 0
energy metabolism 286471 0
inflammatory arthritis 286522 0
Condition category
Condition code
Cardiovascular 286728 286728 0 0
Coronary heart disease
Metabolic and Endocrine 286729 286729 0 0
Diabetes
Inflammatory and Immune System 286730 286730 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: The effect of oral low dose prednisolone on arterial stiffness (assessed by pulse wave analysis from radial artery using Sphygmocor device), sympathetic nervous system activity ( assessed using a task force haemodynamic monitor), energy metabolism (using indirect calorimetry,assessing brown fat activity using FLIR T425 infrared camera) and carbohydrate metabolism (by serial glucose, insulin and C peptide ), in patients aged more than 30years with inflammatory rheumatologic disease will be studied before and after a seven day course of oral prednisolone (mean dose of arm 2). The tests will be done before and 1 to 2.5hours after a mixed meal (10 Kcal/Kg) on the day studied (involves two visits, total duration of 5hours on study day).
Group 2: The effect of oral low dose prednisolone(4 to 10mg/day) on arterial stiffness, sympathetic nervous system activity, energy and carbohydrate metabolism in patients aged more than 30years with inflammatory rheumatologic disease on oral prednisolone for more than 6 months will be studied before and 1 to 2.5 hours after a mixed meal( 10Kcal/Kg). (involves single visit,total duration of 5hours on study day).
Intervention code [1] 284857 0
Treatment: Drugs
Comparator / control treatment
The study include two designs:
Longitudinal study :Subects with inflammatory rheumatological disease who have not received prednisolone for more than 6 months (Group1) will be studied before and after seven day course of prednisolone (mean dose of Group2).
Cross-sectional study: Baseline data from Group 1 will be compared to that of matched subjects on 4-10mg/day of prednisolone for more than 6 months (Group 2) for inflammatory rhematologic disease
Control group
Active

Outcomes
Primary outcome [1] 287129 0
Change in postprandial reduction in Augmentation index
( assessed by pulse wave analysis form radial artery using sphygmocor device) with glucocorticoids.
Timepoint [1] 287129 0
Longitudinal study (acute study):baseline and after seven day course of prednisolone (dose= mean dose of group2).
Cross-sectional study: baseline.
Secondary outcome [1] 297446 0
Effect of glucocorticoid treatment on postprandial changes in sympathetic nervous system activity (assessed by taskforce haemodynamic monitor)
Timepoint [1] 297446 0
Longitudinal study (acute study):baseline and after seven day course of prednisolone (dose= mean dose of group2).
Cross-sectional study: baseline.
Secondary outcome [2] 297447 0
Effect of glucocorticoid treatment on postprandial changes in endothelial function (assessed by peripheral arterial tonometry using Endo-PAT 2000).
Timepoint [2] 297447 0
Longitudinal study (acute study): baseline and after seven day course of prednisolone (dose= mean dose of group2).
Cross-sectional study: baseline.
Secondary outcome [3] 297448 0
Effect of glucocorticoid treatment on postprandial changes in energy metabolism and brown tissue activity ( assessed by indirect calorimetry and infrared thermography using FLIR T425 infrared camera).
Timepoint [3] 297448 0
Longitudinal study (acute study): baseline and after seven day course of prednisolone (dose= mean dose of group2).
Cross-sectional study: baseline.
Secondary outcome [4] 297449 0
Effect of glucocorticoid treatment on insulin sensitivity
( assessed by serial glucose, insulin and C peptide estimation after a mixed meal test).
Timepoint [4] 297449 0
Longitudinal study (acute study): baseline and after seven day course of prednisolone (dose= mean dose of group2).
Cross-sectional study: baseline.
Secondary outcome [5] 297450 0
Effect of glucocorticoid treatment on body composition (assessed by DEXA).
Timepoint [5] 297450 0
baseline

Eligibility
Key inclusion criteria
Group 1 : Has inflammatory rhematologic disease
No prednisolone for >6 months
Age >30years
Group 2 : Has inflammatory rhematologic disease
Taking prednisolone 4 to 10 mg/day for >6months
Age >30years
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Taking oral hypoglycemic agents, insulin or beta blockers
Atrial fibrillation
Inability to provide written informed consent
History of claustrophobia

Study design
Purpose of the study
Treatment
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
Other
Other design features
In the acute study data from participants in Group1 will be compared before and after seven day course of prednisolone.

In the chronic study data from participants in Group2 who are on prednisolone for more than 6 months will be comapared with baseline data of Group1.
Phase
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285253 0
Charities/Societies/Foundations
Name [1] 285253 0
Foundation Daw Park
Country [1] 285253 0
Australia
Funding source category [2] 285254 0
Government body
Name [2] 285254 0
Diabetes Australia Research Trust
Country [2] 285254 0
Australia
Primary sponsor type
Individual
Name
Morton Burt
Address
Staff Specialist,
Southern Adelaide Diabetes and Endocrine Services,
Repatriation General Hospital,
Daws Road,
Daw Park, SA, 5041
Country
Australia
Secondary sponsor category [1] 284116 0
Hospital
Name [1] 284116 0
Southern Adelaide Diabetes and Endocrine Services
Address [1] 284116 0
Repatriation General Hospital,
Daws Road,
Daw Park, SA , 5041
Country [1] 284116 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287265 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 287265 0
Flinders Medical Centre,
The Flats G5- Rooms 3 and 4,
Flinders Drive,
Bedford Park,
SA- 5042.
Ethics committee country [1] 287265 0
Australia
Date submitted for ethics approval [1] 287265 0
Approval date [1] 287265 0
24/04/2012
Ethics approval number [1] 287265 0
11/12/2012

Summary
Brief summary
Glucocorticoids are potent anti inflammatory agents that are used to treat a wide range of inflammatory and rheumatologic conditions. Most patients require a relatively low dose of glucocorticoid for disease control, with one study reporting a mean prednisolone dose of 8mg/day which is approximately 2 to 3 times the physiological glucocorticoid production. The purpose of this study is to investigate :
whether typical therapeutic steroid doses increase the risk of a heart attack.
whether high blood sugars after a meal are related to risk of heart attack.
a novel mechanism by which steroids might increase fat mass through reducing brown fat activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34179 0
Address 34179 0
Country 34179 0
Phone 34179 0
Fax 34179 0
Email 34179 0
Contact person for public queries
Name 17426 0
Anjana Radhakutty
Address 17426 0
Endocrine Registrar
Southern Adelaide Diabetes and Endocrine Services,
Daws Road,
Daw Park -5041
SA
Country 17426 0
Australia
Phone 17426 0
+61 08 82751094
Fax 17426 0
+61 08 82751215
Email 17426 0
[email protected]
Contact person for scientific queries
Name 8354 0
Anjana Radhakutty
Address 8354 0
Endocrine Registrar
Southern Adelaide Diabetes and Endocrine Services,
Daws Road,
Daw Park -5041
SA
Country 8354 0
Australia
Phone 8354 0
+61 08 82751094
Fax 8354 0
+61 08 82751215
Email 8354 0
[email protected]

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

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