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Trial registered on ANZCTR
Registration number
ACTRN12618001846213
Ethics application status
Approved
Date submitted
5/11/2018
Date registered
14/11/2018
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
A cross-sectional pilot study examining the role of circulating immune cells in the presence of type 1 and type 2 diabetes
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Scientific title
A pilot study examining the association of white blood cell morphology and O-GlcNAcylation with the presence of established type 1 and type 2 diabetes
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Secondary ID [1]
296477
0
Nil known
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Universal Trial Number (UTN)
U1111-1222-9871
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Trial acronym
BIT (Blood inflammation trial)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type-1 diabetes
310263
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Type-2 diabetes
310264
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Condition category
Condition code
Metabolic and Endocrine
308993
308993
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0
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
All elective patients (non-diabetic/diabetic) will be invited on the day of their routine visit to participate in the present study.
If the patient agrees to participate, a single 10ml blood sample will be collected for subsequent analysis.
Blood collection will require no more than 10 minutes of the participant's time.
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Intervention code [1]
312800
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Early Detection / Screening
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Comparator / control treatment
COMPARATOR
Healthy, non-diabetic individuals
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Control group
Active
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Outcomes
Primary outcome [1]
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Proportion of participants with increased leukocyte abundance
(Flow cytometric analysis)
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Assessment method [1]
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Timepoint [1]
307952
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Day of collection (immediate)
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Secondary outcome [1]
353449
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The presence of intraleukocyte O-GlcNAcylation as assessed by (composite secondary outcome);
(i) Western blot. Relevant protein abundance using specific monoclonal antibodies (anti-RL2, anti-OGT and anti-OGA) will be utilised to highlight the presence of any O-GlcNAcylation.
(ii) Gene expression assessed by quantitative PCR (Genes of interest: OGT, OGA, GFAT1, GFAT
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Assessment method [1]
353449
0
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Timepoint [1]
353449
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1-3 months post blood collection
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Secondary outcome [2]
353452
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Plasma cytokine levels as assessed by cytokine ELISA assay(s). This is an exploratory outcome and will be determined after flow cytometric analysis,
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Assessment method [2]
353452
0
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Timepoint [2]
353452
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1-3 months post collection
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Eligibility
Key inclusion criteria
Sex: All
Age: 18 - 65 yrs
Inclusion criteria;
Non-diabetic: any healthy, non-diabetic (normoglycemic) individual
Diabetic: Any patients with clinically diagnosed type-1 or type-2 diabetes
Informed consent: participant must be able to give personal informed consent
Participation in the study: participant must be able to co-operate sufficiently to allow the proposed study to progress.
Concomitant medications: no restriction is made in the use of concomitant medications, which will be left to the treating specialist
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Nil known
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Sample size rationale:
Previous studies using the same technique (Springhorn C et al 2012 and Prashilla S 2016), have reported appropriate samples sizes of approximately 30 per group. Although Menart-Houtermans and collegues (2014) have used sample sizes ranging from 60-132 patients to count white blood cells (WBC), the technique employed automated cell counting, which is less reproducible and precise (Tuchin V et al 2011). Based on an expected increase in relevant WBC levels of approximately 20% (power 80%, P = 0.05), 30 T1D 30 T2D patients attending the Diabetes Clinics at the Baker Heart and Diabetes Institute, and 30 non-diabetic individuals from October 2018 will be invited to participate in the study.
Statistical analysis:
For all analyses, a one-way ANOVA will be employed with either a Tukey's or Dunnett's post-hoc test to compare the mean of all experimental groups to one another. Data will be displayed as mean (+/- SD).
Due to the exploratory nature of this study, distribution analyses will be conducted on all data to ensure the correct statistical test is conducted.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/11/2018
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
12317
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Baker Heart and Diabetes Institute - Melbourne
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Recruitment postcode(s) [1]
24553
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
301067
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Other Collaborative groups
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Name [1]
301067
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Baker Heart and Diabetes Institute
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Address [1]
301067
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75 Commercial Road, Melbourne Victoria 3004
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Country [1]
301067
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Baker Heart and Diabetes Institute
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Address
75 Commercial Road, Melbourne Victoria 3004
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Country
Australia
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Secondary sponsor category [1]
300677
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None
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Name [1]
300677
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Address [1]
300677
0
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Country [1]
300677
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301822
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Alfred Hospital; Ethics Committee [EC00315]
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Ethics committee address [1]
301822
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55 Commercial Rd, Melbourne VIC 3004
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Ethics committee country [1]
301822
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Australia
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Date submitted for ethics approval [1]
301822
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09/10/2018
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Approval date [1]
301822
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15/10/2018
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Ethics approval number [1]
301822
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564/18
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Summary
Brief summary
We are aiming to assess the potential differences in immune cell proportions between healthy and diabetic individuals. We hope to identify these differences in order to decipher the gap in knowledge regarding the immune system, diabetes and heart failure.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Rebecca Ritchie
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Address
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Baker Heart and Diabetes Institute
Level 4, 75 Commercial Road, Melbourne, Victoria 3004
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Country
88226
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Australia
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Phone
88226
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+61 414304001
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Fax
88226
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Email
88226
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[email protected]
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Contact person for public queries
Name
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Mr Charles Cohen
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Address
88227
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Baker Heart and Diabetes Institute
Level 4, 75 Commercial Road, Melbourne, Victoria 3004
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Country
88227
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Australia
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Phone
88227
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+61 407396050
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Fax
88227
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Email
88227
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[email protected]
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Contact person for scientific queries
Name
88228
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Mr Charles Cohen
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Address
88228
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Baker Heart and Diabetes Institute
Level 4, 75 Commercial Road, Melbourne, Victoria 3004
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Country
88228
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Australia
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Phone
88228
0
+61 407396050
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Fax
88228
0
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Email
88228
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
It is not yet known if there will be a plan to make IPD available
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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
No additional documents have been identified.
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