Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000409077
Ethics application status
Approved
Date submitted
13/05/2010
Date registered
21/05/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute and chronic effects of glucocorticoids on carbohydrate metabolism in subjects with inflammatory rheumatologic disease.
Scientific title
Acute and chronic effects of glucocorticoids on carbohydrate metabolism in subjects with inflammatory rheumatologic disease.
Secondary ID [1] 251753 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inflammatory rheumatologic disease 257356 0
Condition category
Condition code
Metabolic and Endocrine 257503 257503 0 0
Other metabolic disorders
Cardiovascular 257504 257504 0 0
Other cardiovascular diseases
Inflammatory and Immune System 257531 257531 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prednisolone 4-10mg/day orally for 7-10 days. We will be comparing participants with inflammatory rheumatologic disease who are on prednisolone as usual treatment with those who are not on prednisolone as usual treatment. Participants who are not on prednisolone as usual treatment will undergo a series of investigations and then take a short course of prednisolone. The prednisolone dose will be the mean dose of those who are usually on prednisolone (this group will be studied first). The course of prednisolone will be between 7-10 days, with this period being determined by the timing of repeat investigations. Participants who are on prednisolone as usual treatment will be tested once. Participants who are not on prednisolone as usual treatment will be followed up after 7-10 days for repeat investigations.
Intervention code [1] 256468 0
Other interventions
Intervention code [2] 256487 0
Treatment: Drugs
Comparator / control treatment
Group 2 - Usual treatment including oral prednisolone (4-10mg/day) with no intervention.
Group 1 - Usual treatment does not include prednisolone. These patients will have baseline studies as a control group and then studies after 7-10 days of treatment with oral prednisolone (mean dose of Group 2) to assess the acute effects of low dose prednisolone. The period of 7-10 days will vary depending on availability for investigation bookings.
Baseline studies and those repeated after 7-10 days will be the same. These studies include a deuterated glucose infusion, hyperinsulinaemic-euglycaemic clamp, indirect calorimetry, intravenous glucose tolerance test, assessment of endothelial function, arterial stiffness and baroreceptor sensitivity, as well as a computed tomography (CT) scan abdomen (2 slice) and dual energy x-ray absorptiometry(DXA) scan.
Control group
Active

Outcomes
Primary outcome [1] 258422 0
Change (in those with prednisolone intervention) or difference (between those on prednisolone as usual treatment and those not on prednisolone) in insulin sensitivity as assessed by M value during step 2 of the hyperinsulinaemic euglycaemic clamp
Timepoint [1] 258422 0
Group 1 - investigations will be performed at baseline and at completion of 7-10 days of treatment with oral prednisolone.
Group 2 - investigations will be performed once.
Primary outcome (as above) will be based on results obtained from the investigations.
There will be 12 partcipants in each group, thus the primary outcome will be assessed based on the 12 result sets. Results are based on data and blood samples taken during the hyperinsulinaemic-euglycaemic clamps.
Primary outcome [2] 258423 0
Change (in those with prednisolone intervention) or difference (between those on prednisolone as usual treatment and those not on prednisolone) in pulse wave velocity, as assessed by measurements from the carotid and femoral arteries using a SphygmoCor device.
Timepoint [2] 258423 0
Group 1 - investigations will be performed at baseline and at completion of 7-10 days of treatment with oral prednisolone.
Group 2 - investigations will be performed once.
Primary outcome (as above) will be based on results obtained from the investigations.
There will be 12 partcipants in each group, thus the primary outcome will be assessed based on the 12 result sets. Results are based on data obtained from the SphygmoCor device.
Secondary outcome [1] 264197 0
Change (in those with prednisolone intervention) or difference (between those on prednisolone as usual treatment and those not on prednisolone) in insulin secretion as determined by the intravenous glucose tolerance test
Timepoint [1] 264197 0
Group 1 - investigations will be performed at baseline and at completion of 7-10 days of treatment with oral prednisolone.
Group 2 - investigations will be performed once.
Secondary outcome (as above) will be based on results obtained from blood tests performed after an intravenous bolus of 25% glucose.
There will be 12 partcipants in each group, thus the primary outcome will be assessed based on the 12 result sets.
Secondary outcome [2] 264198 0
Change (in those with prednisolone intervention) or difference (between those on prednisolone as usual treatment and those not on prednisolone) in hepatic glucose output as determined during the final 30 minutes of the basal deuterated glucose infusion by plasma glucose and insulin concentration and glucose isotope enrichment (i.e the proportion of total glucose that is [6,6-2H2] glucose) to calculate basal hepatic glucose production.
Timepoint [2] 264198 0
Group 1 - investigations will be performed at baseline and immediately after 7-10 days of treatment with oral prednisolone.
Group 2 - investigations will be performed once.
Secondary outcome (as above) will be based on results obtained from the investigations.
There will be 12 partcipants in each group, thus the primary outcome will be assessed based on the 12 result sets. Results are based on blood samples taken during the deuterated glucose infusion and hyperinsulinaemic-euglycaemic clamps.
Secondary outcome [3] 264199 0
Change (in those with prednisolone intervention) or difference (between those on prednisolone as usual treatment and those not on prednisolone) in endothelial function as measured by reactive hyperaemia index using an EndoPAT 2000 device.
Timepoint [3] 264199 0
Group 1 - investigations will be performed at baseline and immediately after 7-10 days of treatment with oral prednisolone.
Group 2 - investigations will be performed once.
Secondary outcome (as above) will be based on results obtained from the investigations.
There will be 12 partcipants in each group, thus the primary outcome will be assessed based on the 12 result sets. Results are based on data obtained from the EndoPAT 2000 device.

Eligibility
Key inclusion criteria
Inflammatory rheumatologic disease
Group 1 - not currently on glucocorticoid therapy and have not been on glucocorticoid therapy for at least the last 6 months
Group 2 - currently on glucocorticoid therapy (4-10mg/day), and have been on this therapy for at least 6 months
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of diabetes mellitus;
Inability to provide informed consent;
Medications which significantly affect carbohydrate metabolism;
New York Heart Association (NYHA) class IV cardiac failure;
Severe renal or hepatic disease;
Inability to lie flat for 6 hours

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
24/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256962 0
Charities/Societies/Foundations
Name [1] 256962 0
Diabetes Australia Research Trust
Country [1] 256962 0
Australia
Funding source category [2] 256963 0
Charities/Societies/Foundations
Name [2] 256963 0
Foundation Daw Park
Country [2] 256963 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] 256226 0
None
Name [1] 256226 0
Address [1] 256226 0
Country [1] 256226 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258981 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 258981 0
Human Research and Ethics Department
Southern Adelaide Health Service
Room 2A 221
Flinders Medical Centre
Bedford Park
SA 5042
Ethics committee country [1] 258981 0
Australia
Date submitted for ethics approval [1] 258981 0
15/02/2010
Approval date [1] 258981 0
06/04/2010
Ethics approval number [1] 258981 0
EC00188

Summary
Brief summary
The study aims to assess:
* How low dose steroids affect insulin secretion and sensitivity
* Whether low dose steroids increase the risk of heart disease
We hope that this information will increase understanding of the risk of diabetes conferred by low dose steroids and how best to treat it.
We will be studying participants with inflammatory joint disease. One group of participants will usually take prednisolone (a steroid tablet) for their joint disease. They will be studied once. The other group of participants will not usually be treated with prednisolone for their joint disease. This group of participants will be studied, and then they will be asked to take low dose prednisolone for 7-10 days before being studied again.
On the first study day we will assess how sensitive the body is to insulin with an insulin clamp study. On the second day we will assess the risk of heart disease, how much insulin the body is making and body composition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31158 0
Address 31158 0
Country 31158 0
Phone 31158 0
Fax 31158 0
Email 31158 0
Contact person for public queries
Name 14405 0
Carolyn Petersons
Address 14405 0
Southern Adelaide Diabetes and Endocrine Services, Repatriation General Hospital
Daws Rd
Daw Park
SA 5041
Country 14405 0
Australia
Phone 14405 0
+61 8 8275 1094
Fax 14405 0
Email 14405 0
carolyn.petersons@health.sa.gov.au
Contact person for scientific queries
Name 5333 0
Carolyn Petersons
Address 5333 0
Southern Adelaide Diabetes and Endocrine Services, Repatriation General Hospital
Daws Rd
Daw Park
SA 5041
Country 5333 0
Australia
Phone 5333 0
+61 8 8275 1094
Fax 5333 0
Email 5333 0
carolyn.petersons@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
EmbaseLow dose prednisolone and insulin sensitivity differentially affect arterial stiffness and endothelial function: An open interventional and cross-sectional study.2017https://dx.doi.org/10.1016/j.atherosclerosis.2017.01.033
N.B. These documents automatically identified may not have been verified by the study sponsor.