Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000811202
Ethics application status
Approved
Date submitted
7/09/2009
Date registered
17/09/2009
Date last updated
17/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Urinary sodium excretion in type 2 diabetes
Scientific title
A comparison of urinary sodium and potassium excretion in males and females with type 2 diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 243687 0
Condition category
Condition code
Diet and Nutrition 239952 239952 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 240007 240007 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measurement of 24 hour urinary sodium and potassium excretion. Patients were given instructions on how to complete 24 hour urine collections. Plastic urine bottles were supplied. Urine specimens were analysed soon after the collection at a central laboratory. The specimens were collected between 2000- 2008
Intervention code [1] 241230 0
Not applicable
Comparator / control treatment
This is an observational study. Measurement of urinary sodium excretion
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240758 0
Measurement of urinary sodium excretion using Austin Health biochemistry lab. Urine volume was recorded by weighing the specimen. Urine sodium and potassium were analysed o the Beckman Coulter UniCel DXC800/600 System (s) Anayzer
Timepoint [1] 240758 0
8years, on average twice or three times per year
Secondary outcome [1] 257428 0
Measurement of urinary potassium excretionusing Austin Health biochemistry lab. Urine volume was recorded by weighing the specimen. Urine potassium were analysed o the Beckman Coulter UniCel DXC800/600 System (s) Anayzer
Timepoint [1] 257428 0
8 years. Twice or three times per year

Eligibility
Key inclusion criteria
Type 2 diabetes
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 Diabetes

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243609 0
Government body
Name [1] 243609 0
National Health and Medical Research Council has funded the scholarship of the primary investigator
Country [1] 243609 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg
Victoria
Australia 3084
Country
Australia
Secondary sponsor category [1] 237058 0
None
Name [1] 237058 0
Address [1] 237058 0
Country [1] 237058 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Despite the recognised association between salt intake and blood pressure, there have been no studies documenting salt consumption in patients with type 2 diabetes. We hypothesized that the majority of patients with type 2 diabetes may not comply with the recommended guidelines for sodium intake.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30159 0
Address 30159 0
Country 30159 0
Phone 30159 0
Fax 30159 0
Email 30159 0
Contact person for public queries
Name 13406 0
Elif Ekinci
Address 13406 0
Department of Endocrinology
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg West
Victoria
Australia, 3081
Country 13406 0
Australia
Phone 13406 0
+61394965489
Fax 13406 0
Email 13406 0
[email protected]
Contact person for scientific queries
Name 4334 0
Elif Ekinci
Address 4334 0
Department of Endocrinology
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg West
Victoria
Australia, 3081
Country 4334 0
Australia
Phone 4334 0
+61394965489
Fax 4334 0
Email 4334 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
No additional documents have been identified.