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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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
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

Study type
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
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

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

Key inclusion criteria
Patients with Type 2 Diabetes
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264679 0
Name [1] 264679 0
University of South Australia
Address [1] 264679 0
City East Campus
University of South Australia
PO Box 2471
Adelaide SA 5000
Country [1] 264679 0
Primary sponsor type
University of South Australia
School of Pharmacy and Medical Science
City East Campus
University of South Australia
PO Box 2471
Adelaide SA 5000
Secondary sponsor category [1] 263830 0
Name [1] 263830 0
Address [1] 263830 0
Country [1] 263830 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 266689 0
Approval date [1] 266689 0
Ethics approval number [1] 266689 0

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

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
Phone 32351 0
+61 8 8302 2579
Fax 32351 0
Email 32351 0
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
Phone 15598 0
+61 8 8302 2579
Fax 15598 0
Email 15598 0
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
Phone 6526 0
+61 8 8302 2579
Fax 6526 0
Email 6526 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Journal publication details
Publication date and citation/details [1] 6204 0
Kristina S. Petersen, David J. Torpy, Ian M. Chapman, Sanghamitra Guha, Peter M. Clifton, Kirsty Turner, Jennifer B. Keogh 2013, Food label education does not reduce sodium intake in people with type 2 diabetes mellitus. A randomised controlled trial, Appetite, Volume 68, Pages 147-151,
Other publications
Have study results been made publicly available in another format?
Results – plain English summary
In a 3 month randomised controlled trial, 78 men (n= 49) and women (n= 29) with T2DM wererecruited from a Diabetes Centre at a University teaching hospital. The intervention group was educated in a single session to use the nutrition information panel on food labels to choose products which com-plied with the Food Standards Australia New Zealand (FSANZ) guideline of <120 mg sodium/100 g food.The control group continued on their usual diet. At 3 months mean urinary sodium excretion was unchanged in the intervention (174mmol/24 h and 175mmol/24 h) and control group (167mmol/24 h and 161mmol/24 h),with no differences between groups.