Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001052820
Ethics application status
Approved
Date submitted
25/09/2012
Date registered
3/10/2012
Date last updated
23/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The correlation between dietary intake and carotid intima media thickness in people with diabetes
Scientific title
A cross-sectional study to determine the dietary correlates of carotid intima media thickness in people with diabetes
Secondary ID [1] 281291 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 and type 2 diabetes 287501 0
Condition category
Condition code
Diet and Nutrition 287827 287827 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 287886 287886 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this cross-sectional study is to determine the correlation between dietary intake and carotid intima media thickness. Each participant will provide data at one timepoint only. Participants will complete the DQES (V2) food frequency questionnaire. A spot urine sample and a fasting serum sample will be collected. Ultrasound measurement of the carotid artery will be done to determine intima media thickness and carotid compliance and stiffness. Blood pressure will also be measured. Testing will take approximately 1-1.5hours.

The correlation between dietary intake of specific food and nutrients will be determined by multiple regression analysis.
Intervention code [1] 285760 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288048 0
The association between dietary intake, as measured by the DQES (V2) food frequency questionnaire, and carotid intima media thickness, measured by B mode ultrasound.
Timepoint [1] 288048 0
Each participant on one visit (baseline)
Secondary outcome [1] 299337 0
The correlation between dietary intake, as measured by the DQES (V2) food frequency questionnaire, and ultrasound measures of the vascular compliance and stiffness in the carotid artery
Timepoint [1] 299337 0
Each participants on one visit (baseline)
Secondary outcome [2] 299338 0
The correlation between dietary intake, as measured by the DQES (V2) food frequency questionnaire and augmentation index, central augmented pressure and carotid-femoral pulse wave velocity.
Timepoint [2] 299338 0
Each participant on one visit (baseline)

Eligibility
Key inclusion criteria
Diagnosed type 1 or type 2 diabetes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cancer
Unstable cardiovascular disease requiring active intervention such as CABG or stenting in the next 3-4 months
Heart failure of any degree
Significant renal impairment i.e. eGFR <30ml/min
Liver disease of any degree

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/10/2012
Actual
8/10/2012
Date of last participant enrolment
Anticipated
Actual
8/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 5783 0
5000

Funding & Sponsors
Funding source category [1] 286053 0
University
Name [1] 286053 0
University of South Australia
Country [1] 286053 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
City East Campus
University of South Australia
GPO Box 2471
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 284866 0
None
Name [1] 284866 0
Address [1] 284866 0
Country [1] 284866 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288105 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 288105 0
Ethics committee country [1] 288105 0
Australia
Date submitted for ethics approval [1] 288105 0
03/09/2012
Approval date [1] 288105 0
24/09/2012
Ethics approval number [1] 288105 0
0000030650

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34750 0
A/Prof Jennifer Keogh
Address 34750 0
University of South Australia City East Campus North Terrace Adelaide SA 5000
Country 34750 0
Australia
Phone 34750 0
+61 8 8302 2579
Fax 34750 0
Email 34750 0
[email protected]
Contact person for public queries
Name 17997 0
Associate Professor Jennifer Keogh
Address 17997 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 17997 0
Australia
Phone 17997 0
+61 8 8302 2579
Fax 17997 0
Email 17997 0
[email protected]
Contact person for scientific queries
Name 8925 0
Associate Professor Jennifer Keogh
Address 8925 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 8925 0
Australia
Phone 8925 0
+61 8 8302 2579
Fax 8925 0
Email 8925 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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDietary predictors of arterial stiffness in a cohort with type 1 and type 2 diabetes.2015https://dx.doi.org/10.1016/j.atherosclerosis.2014.12.012
EmbaseClinical and dietary predictors of common carotid artery intima media thickness in a population with type 1 and type 2 diabetes: A cross-sectional study.2017https://dx.doi.org/10.4239/wjd.v8.i1.18
N.B. These documents automatically identified may not have been verified by the study sponsor.