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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 296477 0
Nil known
Universal Trial Number (UTN)
U1111-1222-9871
Trial acronym
BIT (Blood inflammation trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type-1 diabetes 310263 0
Type-2 diabetes 310264 0
Condition category
Condition code
Metabolic and Endocrine 308993 308993 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 312800 0
Early Detection / Screening
Comparator / control treatment
COMPARATOR
Healthy, non-diabetic individuals
Control group
Active

Outcomes
Primary outcome [1] 307952 0
Proportion of participants with increased leukocyte abundance
(Flow cytometric analysis)
Timepoint [1] 307952 0
Day of collection (immediate)
Secondary outcome [1] 353449 0
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
Timepoint [1] 353449 0
1-3 months post blood collection
Secondary outcome [2] 353452 0
Plasma cytokine levels as assessed by cytokine ELISA assay(s). This is an exploratory outcome and will be determined after flow cytometric analysis,
Timepoint [2] 353452 0
1-3 months post collection

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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil known

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
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.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12317 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 24553 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 301067 0
Other Collaborative groups
Name [1] 301067 0
Baker Heart and Diabetes Institute
Address [1] 301067 0
75 Commercial Road, Melbourne Victoria 3004
Country [1] 301067 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Baker Heart and Diabetes Institute
Address
75 Commercial Road, Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 300677 0
None
Name [1] 300677 0
Address [1] 300677 0
Country [1] 300677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301822 0
Alfred Hospital; Ethics Committee [EC00315]
Ethics committee address [1] 301822 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 301822 0
Australia
Date submitted for ethics approval [1] 301822 0
09/10/2018
Approval date [1] 301822 0
15/10/2018
Ethics approval number [1] 301822 0
564/18

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88226 0
Prof Rebecca Ritchie
Address 88226 0
Baker Heart and Diabetes Institute
Level 4, 75 Commercial Road, Melbourne, Victoria 3004
Country 88226 0
Australia
Phone 88226 0
+61 414304001
Fax 88226 0
Email 88226 0
rebecca.ricthie@baker.edu.au
Contact person for public queries
Name 88227 0
Mr Charles Cohen
Address 88227 0
Baker Heart and Diabetes Institute
Level 4, 75 Commercial Road, Melbourne, Victoria 3004
Country 88227 0
Australia
Phone 88227 0
+61 407396050
Fax 88227 0
Email 88227 0
charlie.cohen@baker.edu.au
Contact person for scientific queries
Name 88228 0
Mr Charles Cohen
Address 88228 0
Baker Heart and Diabetes Institute
Level 4, 75 Commercial Road, Melbourne, Victoria 3004
Country 88228 0
Australia
Phone 88228 0
+61 407396050
Fax 88228 0
Email 88228 0
charlie.cohen@baker.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
It is not yet known if there will be a plan to make IPD available
What supporting documents are/will be available?
No other documents available
Summary results
No Results