Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000063617
Ethics application status
Approved
Date submitted
26/07/2005
Date registered
1/08/2005
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Date results information initially provided
8/06/2021
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
Secondary ID [1] 304433 0
Nil known
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
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.
Control group
Active

Outcomes
Primary outcome [1] 190 0
Change in HbA1c from baseline to 12 months
Timepoint [1] 190 0
12 months
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
5/05/2005
Actual
5/05/2005
Date of last participant enrolment
Anticipated
Actual
15/12/2005
Date of last data collection
Anticipated
Actual
15/12/2015
Sample size
Target
110
Accrual to date
Final
108
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
Country [1] 206 0
Australia
Primary sponsor type
Other
Name
International Diabetes Institute
Address
260 Kooyong Road
Caulfield, Victoria 3162
Country
Australia
Secondary sponsor category [1] 155 0
University
Name [1] 155 0
Royal Melbourne Institute of Technology
Address [1] 155 0
124 La Trobe Street, Melbourne VIC 3000
Country [1] 155 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308710 0
International Diabetes Institute
Ethics committee address [1] 308710 0
260 Kooyong Road
Caulfield
Victoria 3162
Ethics committee country [1] 308710 0
Australia
Date submitted for ethics approval [1] 308710 0
15/02/2005
Approval date [1] 308710 0
15/03/2005
Ethics approval number [1] 308710 0
03/2005

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
Main outcomes published:
R. N. Larsen & N. J. Mann & E. Maclean & J. E. Shaw
The effect of high-protein, low-carbohydrate diets in the treatment of type 2 diabetes: A 12 month randomised controlled trial
Diabetologia (2011) 54:731–740
Public notes

Contacts
Principal investigator
Name 36333 0
A/Prof Jonathan Shaw
Address 36333 0
Baker IDI Heart and Diabetes Institute
99 Commercial Road
Melbourne 3004
Victoria
Country 36333 0
Australia
Phone 36333 0
+61 3 8532 1821
Fax 36333 0
Email 36333 0
[email protected]
Contact person for public queries
Name 9256 0
Mrs 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
[email protected]
Contact person for scientific queries
Name 184 0
A/Prof Jonathan Shaw
Address 184 0
Baker IDI Heart and Diabetes Institute
99 Commercial Road
Melbourne 3004
Victoria
Country 184 0
Australia
Phone 184 0
+61 3 8532 1821
Fax 184 0
Email 184 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All study variables as available.
When will data be available (start and end dates)?
1 November 2020 to 31 December 2025
Available to whom?
Researchers with ethics approval
Available for what types of analyses?
Any purpose could be considered.
How or where can data be obtained?
As approved by the PI ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes The effect of high-protein, low-carbohydrate diets... [More Details]
Plain language summaryNo There is no long-term metabolic benefit of a high-... [More Details]

Documents added automatically
No additional documents have been identified.