Trial Review

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
ACTRN12613000251729
Ethics application status
Approved
Date submitted
1/03/2013
Date registered
4/03/2013
Date last updated
23/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of diet on risk of heart disease in people with diabetes
Scientific title
The effect of improving diet quality on measures of vascular function in people with type 1 and type 2 diabetes
Secondary ID [1] 282045 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 288516 0
Condition category
Condition code
Diet and Nutrition 288847 288847 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 288848 288848 0 0
Diabetes
Public Health 288849 288849 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a longitudinal randomised controlled trial with a 12 month intervention phase. Participants in the intervention group will be advised to increase their consumption of fruit (1 extra serve/day), vegetables (2 extra serves/day) and dairy (1 extra serve/day. Participants will choose which fruit, vegetables and dairy products they would like to increase their intake of.
Intervention code [1] 286635 0
Treatment: Other
Intervention code [2] 286636 0
Lifestyle
Comparator / control treatment
The control group will not receive any dietary advie and will continue to consume their usual diet
Control group
Active

Outcomes
Primary outcome [1] 288975 0
Carotid intima media progression assessed using B mode ultrasound
Timepoint [1] 288975 0
At baseline and 1 year
Secondary outcome [1] 301478 0
Central augmentation index, augmented pressure and pulse wave velocity measured using Sphygmo-CorEXCEL
Timepoint [1] 301478 0
Baseline, 3, 6, 9, 12 months
Secondary outcome [2] 301479 0
Ultrasound measures of vascular compliance and stiffness in the carotid artery
Timepoint [2] 301479 0
Baseline, 3, 6, 9, 12 months
Secondary outcome [3] 301480 0
Blood pressure measured using a automated sphygmomanometer
Timepoint [3] 301480 0
Baseline, 3, 6, 9, 12 months
Secondary outcome [4] 301481 0
Serum biomarkers of vascular function
Timepoint [4] 301481 0
Baseline, 3, 6, 9, 12 months

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 3-4months
Heart failkure of any degree
Significant renal impairment i.e. eGFR <30ml/min
Liver disease of any degree

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study will be publically advertised. Participants will be randomised by computer generated random numbers to either the intervention or control group. Allocation will not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers will be generated using a computer program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/12/2012
Actual
7/12/2012
Date of last participant enrolment
Anticipated
31/07/2013
Actual
14/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 6444 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 286818 0
University
Name [1] 286818 0
University of South Australia
Country [1] 286818 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] 285606 0
None
Name [1] 285606 0
Address [1] 285606 0
Country [1] 285606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288884 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 288884 0
Ethics committee country [1] 288884 0
Australia
Date submitted for ethics approval [1] 288884 0
Approval date [1] 288884 0
11/07/2012
Ethics approval number [1] 288884 0
0000028802

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

Contacts
Principal investigator
Name 38226 0
A/Prof Jennifer Keogh
Address 38226 0
University of South Australia City East Campus North Terrace Adelaide SA 5000
Country 38226 0
Australia
Phone 38226 0
+618 83022579
Fax 38226 0
Email 38226 0
[email protected]
Contact person for public queries
Name 38227 0
Jennifer Keogh
Address 38227 0
University of South Australia City East Campus North Terrace Adelaide SA 5000
Country 38227 0
Australia
Phone 38227 0
+618 83022579
Fax 38227 0
Email 38227 0
[email protected]
Contact person for scientific queries
Name 38228 0
Jennifer Keogh
Address 38228 0
University of South Australia City East Campus North Terrace Adelaide SA 5000
Country 38228 0
Australia
Phone 38228 0
+618 83022579
Fax 38228 0
Email 38228 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
EmbaseEffect of improving dietary quality on carotid intima media thickness in subjects with type 1 and type 2 diabetes: A 12-mo randomized controlled trial.2015https://dx.doi.org/10.3945/ajcn.115.112151
EmbaseEffect of improving dietary quality on arterial stiffness in subjects with type 1 and type 2 diabetes: A 12 months randomised controlled trial.2016https://dx.doi.org/10.3390/nu8060382
N.B. These documents automatically identified may not have been verified by the study sponsor.