Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000348954
Ethics application status
Approved
Date submitted
29/03/2011
Date registered
4/04/2011
Date last updated
17/12/2019
Date data sharing statement initially provided
17/12/2019
Date results information initially provided
17/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in sodium excretion in people with diabetes following dietary advice
Scientific title
Changes in sodium excretion in people with Type 2 diabetes following dietary advice
Secondary ID [1] 259799 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 261381 0
Condition category
Condition code
Diet and Nutrition 259538 259538 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 265647 265647 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to determine the effects of dietary education to reduce sodium intake compared with usual care on sodium excretion of people with type 2 diabetes. This is a parallel study of 2 groups and the intervention will be for 12 months, with weight, height and blood pressure measured at the beginning, at 3 months and the end of the study. Urine samples will also be measured and 24-hour food recalls will be conducted. The target salt intake will be 5g/day for women and 6g/day for men. Patients will meet with a dietitian one-on-one for approximately 15 minutes at the beginning of the study and again at three months. The dietary education will be focused on using the FSANZ low sodium guideline of 120mg/100g food. A simple pictorial education tool containing pictures of appropriate foods will be used and participants will be provided with a booklet containing a 2 week cycle of menus, recipes to guide food preparation, tips for adapting usual recipes, tips for eating out and social occasions. Participants will also be provided with a sodium content of favourite foods and how to include these while maintaining a reduced salt intake.
Intervention code [1] 264231 0
Treatment: Other
Intervention code [2] 264301 0
Lifestyle
Comparator / control treatment
One group will receive usual care, defined as usual dietary education with no specific advice on sodium reduction. The other will receive additional dietary advice regarding sodium intake.
Control group
Active

Outcomes
Primary outcome [1] 262344 0
Sodium excretion measured by 24 hour urinary collection
Timepoint [1] 262344 0
Baseline, three and twelve months
Primary outcome [2] 266451 0
Blood pressure measured by automated sphygmomanometer (mean of three measurements)
Timepoint [2] 266451 0
Baseline, three and twelve months
Secondary outcome [1] 273588 0
Dietary assessment measured by 24 hour recall
Timepoint [1] 273588 0
Baseline, three and twelve months
Secondary outcome [2] 273801 0
Blood pressure medications, dose and type
Timepoint [2] 273801 0
Baseline, three and twelve months

Eligibility
Key inclusion criteria
Patients with Type 2 Diabetes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18; any condition that affects sodium/fluid balance, including heart, liver or kidney impairment, diuretic use, idiopathic oedema, hypoalbuminaemia, primary aldosteronism, hyperhidrosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be invited to participate in the study and provided with written information. Following their consent they will be randomised to either usual care or sodium reduction. Allocation is not 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
1/06/2011
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
16/12/2011
Date of last data collection
Anticipated
Actual
31/03/2012
Sample size
Target
60
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 264679 0
University
Name [1] 264679 0
University of South Australia
Country [1] 264679 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
School of Pharmacy and Medical Science
City East Campus
University of South Australia
PO Box 2471
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 263830 0
None
Name [1] 263830 0
Address [1] 263830 0
Country [1] 263830 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266689 0
Royal Adelaide Hospital
Ethics committee address [1] 266689 0
North Terrace
Adelaide SA 5000
Ethics committee country [1] 266689 0
Australia
Date submitted for ethics approval [1] 266689 0
28/03/2011
Approval date [1] 266689 0
11/04/2011
Ethics approval number [1] 266689 0

Summary
Brief summary
There is a long established link between dietary salt intake and blood pressure, and hypertension is common in people with type 2 diabetes mellitus. Breads and cereals are high in salt, so the recommendation that people with diabetes should consume a high carbohydrate diet may lead to high salt intakes and make blood pressure more difficult to manage. This study will determine the effect of giving people with type 2 diabetes additional dietary education to reduce their salt intake.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32351 0
A/Prof Jennifer Keogh
Address 32351 0
University of South Australia City East Campus North Terrace Adelaide SA 5000
Country 32351 0
Australia
Phone 32351 0
+61 8 8302 2579
Fax 32351 0
Email 32351 0
jennifer.keogh@unisa.edu.au
Contact person for public queries
Name 15598 0
A/Prof Dr. Jennifer Keogh
Address 15598 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 15598 0
Australia
Phone 15598 0
+61 8 8302 2579
Fax 15598 0
Email 15598 0
jennifer.keogh@unisa.edu.au
Contact person for scientific queries
Name 6526 0
A/Prof Dr. Jennifer Keogh
Address 6526 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 6526 0
Australia
Phone 6526 0
+61 8 8302 2579
Fax 6526 0
Email 6526 0
jennifer.keogh@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD data will be available as this was not approved by Ethics.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.