Trial registered on ANZCTR


Trial ID
ACTRN12605000063617
Ethics application status
Approved
Date submitted
26/07/2005
Date registered
1/08/2005
Date last updated
1/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of high protein, low carbohydrate diets in the treatment of type 2 diabetes
Scientific title
The effect of high protein, low carbohydrate diets on glycaemic control and weight in the treatment of type 2 diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 135 0
Condition category
Condition code
Metabolic and Endocrine 154 154 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomised to one of two diets - (1) high carbohydrate, low protein (55% CHO, 15% pr, 30% fat) or (2) low carbohydrate, high protein (40% CHO, 30% pr, 30% fat), over 12 months.
Intervention code [1] 67 0
Lifestyle
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 190 0
Change in HbA1c from baseline to 12 months
Timepoint [1] 190 0
Secondary outcome [1] 439 0
Weight, and other anthropometric measurements.
Timepoint [1] 439 0
Changes from baseline to 12 months.
Secondary outcome [2] 440 0
Lipids
Timepoint [2] 440 0
Changes from baseline to 12 months.
Secondary outcome [3] 441 0
Urinary albumin and calcium excretion.
Timepoint [3] 441 0
Changes from baseline to 12 months.
Secondary outcome [4] 442 0
Compliance with diet
Timepoint [4] 442 0
At 3, 6 and 12 months.

Eligibility
Key inclusion criteria
Patients participating in the study will have type 2 diabetes, with body mass index (BMI) between 27 and 40 kg/m2, and HbA1c between 6.5 and 10%. Women of childbearing potential will need to agree to take adequate contraception throughout the study period.Prior to study entry, weight should be stable, with no more than 3 kg change in the previous 3 months.
Minimum age
30 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have significant heart disease (unstable angina, cardiac failure, or recent [within the previous 3 months] MI, CABG or other coronary intervention), stroke within the previous 3 months, renal disease (proteinuria or serum creatinine > 0.13 mmol/l), liver disease or malignancy.

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)
Sealed envelopes are held by an independent person, and opened by the independent person to assign the intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers (Excel), in blocks. Stratified by diabetes treatment modality into 3 strata - diet controlled, tablet treatment, insulin treatment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 206 0
Commercial sector/Industry
Name [1] 206 0
Meat and Livestock Australia
Address [1] 206 0
Country [1] 206 0
Australia
Primary sponsor type
Other
Name
International Diabetes Institute
Address
Country
Australia
Secondary sponsor category [1] 155 0
University
Name [1] 155 0
Royal Melbourne Institute of Technology
Address [1] 155 0
Country [1] 155 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study will determine if high protein, low carbohydrate diets are superior to standard high carbohydrate diets in people with type diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36333 0
Address 36333 0
Country 36333 0
Phone 36333 0
Fax 36333 0
Email 36333 0
Contact person for public queries
Name 9256 0
Elizabeth Maclean
Address 9256 0
International Diabetes Institute
250 Kooyong Rd
Caulfield VIC 3162
Country 9256 0
Australia
Phone 9256 0
+61 3 92585050
Fax 9256 0
Email 9256 0
emaclean@idi.org.au
Contact person for scientific queries
Name 184 0
A. Prof Jonathan Shaw
Address 184 0
International Diabetes Institute
250 Kooyong Rd
Caulfield VIC 3162
Country 184 0
Australia
Phone 184 0
+61 3 92585050
Fax 184 0
Email 184 0
jshaw@idi.org.au