Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000676819
Ethics application status
Approved
Date submitted
13/06/2012
Date registered
25/06/2012
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Higher protein, lower carbohydrate diet to reduce glycated haemoglobin (HbA1c)
Scientific title
Higher protein, lower carbohydrate diet to reduce glycated haemoglobin (HbA1c) in people with type 2 diabetes
Secondary ID [1] 280657 0
Nil
Universal Trial Number (UTN)
U1111-1131-7631
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus (type 2) 286678 0
Condition category
Condition code
Metabolic and Endocrine 286981 286981 0 0
Diabetes
Diet and Nutrition 287076 287076 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a 6 month translational style study with non-standard dietary advice given to the intervention group on only two occasions (baseline and 3 months) in the form of 2 x 30 min consultations with a nutritionist and take home information sheets. The dietary advice will be to omit all salty snacks, sweets, cake and biscuits, pies and pasties and replace them with 2-3 pieces fruit/day or low fat dairy (e.g. yoghurts). Breakfast of cereal/toast will be replaced on 2 mornings per week with lean meat (e.g. steak or fish) and eggs. Lunch will be lean meat/fish/cheese/egg salad on 3 days per week with no bread/biscuits. Dinner will be lean meat- steaks or casserole/lean beef/chicken/fish with unlimited green vegetables and pumpkin. Volunteers have the option of including small amounts of starchy carbohydrate in their main meal (rice/pasta/potato) for 1-2 meals per week.

Weight loss may occur but is not a requirement or objective of the study. Results will be analysed taking into account any weight loss that occurs.
Intervention code [1] 285065 0
Lifestyle
Intervention code [2] 285066 0
Treatment: Other
Comparator / control treatment
Use of a control group who will receive standard care in the form of general healthy eating advice suitable for the general population. This will be provided in the form of a pamphlet (Australian Guide to Healthy Eating) or as a book (Total Life Diet by Shamala Ratnesar), with volunteers randomised to receive either the pamphlet or book.
Control group
Active

Outcomes
Primary outcome [1] 287316 0
HbA1c using fasting venous blood samples
Timepoint [1] 287316 0
Baseline (0 months), 3 months and 6 months.
Secondary outcome [1] 297890 0
A single spot urine sample will also be collected on these three occasions and analysed for sodium and potassium/creatinine ratio.
Timepoint [1] 297890 0
Baseline (0 months), 3 months and 6 months.
Secondary outcome [2] 297891 0
Dietary intake. All volunteers (intervention and control) will be required to complete a food diary listing all foods and drinks consumed, along with approximate amounts.
Timepoint [2] 297891 0
3 consecutive days of every month from baseline to 6 months (6 times in total).
Secondary outcome [3] 298063 0
Body weight - measured using scientific-quality scales
Timepoint [3] 298063 0
Baseline (0 months), 3 months and 6 months
Secondary outcome [4] 298064 0
Blood pressure - measured using standard medical sphygmomanometer in clinic
Timepoint [4] 298064 0
Baseline (0 months), 3 months and 6 months.
Secondary outcome [5] 298065 0
Fasting blood glucose using fasting venous blood samples
Timepoint [5] 298065 0
Baseline (0 months), 3 months and 6 months.
Secondary outcome [6] 298066 0
Fasting lipids using fasting venous blood samples
Timepoint [6] 298066 0
Baseline (0 months), 3 months and 6 months.

Eligibility
Key inclusion criteria
i) Type 2 diabetes
ii) HbA1c greater than 7.5% within the last 6 months - maybe unmedicated for diabetes or on insulin or oral hypoglycaemic medication
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bariatric surgery, pregnant / lactating, not following a low carbohydrate diet within the last 3 months

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)
Both the researcher who determined if the subject was eligible for inclusion in the trial, and the subject, were not aware of which group (intervention or control) the subject would be allocated to. Allocation was then centrally performed by computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (1:1) by using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Recruitment is rolling i.e. not all participants will start on the same date, rather there will be multiple intakes over a period of 4 - 6 weeks.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285426 0
Self funded/Unfunded
Name [1] 285426 0
Peter Clifton
Country [1] 285426 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Baker IDI Heart & Diabetes Institute
Address
75 Commercial Rd
Prahran 3004
Melbourne VIC
Country
Australia
Secondary sponsor category [1] 284279 0
Individual
Name [1] 284279 0
Peter Clifton
Address [1] 284279 0
GPO Box 664 Adelaide SA 5001
Country [1] 284279 0
Australia
Other collaborator category [1] 276860 0
Individual
Name [1] 276860 0
Shamala Ratnesar
Address [1] 276860 0
PO Box 763
Strathfield NSW 2135
Country [1] 276860 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287437 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 287437 0
Ground Floor, Linay Pavilion,
The Alfred Hospital,
Commercial Road,
Melbourne.
VIC 3004
Ethics committee country [1] 287437 0
Australia
Date submitted for ethics approval [1] 287437 0
Approval date [1] 287437 0
05/06/2012
Ethics approval number [1] 287437 0
Approval number 228/12

Summary
Brief summary
The research project aims to show by offering a relatively flexible and straightforward dietary regimen low in carbohydrate (replaced with protein and/or unsaturated fat) to poorly controlled type 2 diabetes patients (HbA1c >7.5%), HbA1c will be significantly reduced over a period of 6 months in the absence of weight loss.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34301 0
Address 34301 0
Country 34301 0
Phone 34301 0
Fax 34301 0
Email 34301 0
Contact person for public queries
Name 17548 0
Prof Peter Clifton
Address 17548 0
GPO Box 664 Adelaide SA 5001
Country 17548 0
Australia
Phone 17548 0
+61884629702
Fax 17548 0
Email 17548 0
[email protected]
Contact person for scientific queries
Name 8476 0
Prof Peter Clifton
Address 8476 0
GPO Box 664 Adelaide SA 5001
Country 8476 0
Australia
Phone 8476 0
+61884629702
Fax 8476 0
Email 8476 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.