Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000045314
Ethics application status
Approved
Date submitted
18/12/2007
Date registered
29/01/2008
Date last updated
29/01/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised study to evaluate a high protein weight loss diet Vs a low glycaemic index diet on renal function in subjects with early diabetic nepropathy who are overweight.
Scientific title
A randomised study to evaluate a high protein weight loss diet Vs a low glycaemic index diet on renal function in subjects with early diabetic nepropathy who are overweight.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic nephropathy 2643 0
High protein weight loss diets 2644 0
Condition category
Condition code
Diet and Nutrition 2770 2770 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects with early diabetic nepropathy who are overweight and randomized to receive a high protein weight loss diet. The protein content will be 30-35% of total energy. Diet will last for 12 months. Protein will be mainly by red meat consumed four times a week.
Intervention code [1] 2379 0
Lifestyle
Intervention code [2] 2392 0
Behaviour
Comparator / control treatment
Overweight diabetic nephropathy subjects who will receive a low glycaemic index diet. This will involve high fibre carbohydrate sources such as high fibre cereal, vegetables and fruit. The diet will last for 12 months.
Control group
Active

Outcomes
Primary outcome [1] 3645 0
Estimated glomerular filtration rate (GMR) by blood testing.
Timepoint [1] 3645 0
One week prior to the medical stabilisation period and after three months and then every 4 months for 12 months.
Primary outcome [2] 3656 0
Cystatin c blood measurement.
Timepoint [2] 3656 0
One week prior to the medical stabilisation period and after three months and then every 4 months for 12 months.
Primary outcome [3] 3657 0
Albumin excretion rate on 24 hour urine sample.
Timepoint [3] 3657 0
At start and end of the 12 month dietary period.
Secondary outcome [1] 6120 0
HbA1C blood test
Timepoint [1] 6120 0
At baseline and every 4 months.
Secondary outcome [2] 6177 0
Lipid by blood test
Timepoint [2] 6177 0
At baseline and every 4 months.
Secondary outcome [3] 6178 0
Whole body composition by DEXA (dual energy x-ray absorptiometry) scan.
Timepoint [3] 6178 0
At the start of the 12 months and at the end of the 12 months.
Secondary outcome [4] 6179 0
Continuous blood glucose monitoring for 3 days.
Timepoint [4] 6179 0
At start and end of the study.
Secondary outcome [5] 6180 0
Nuclear medicine technetium measurement of renal function.
Timepoint [5] 6180 0
At start and end of the 12 month dietary period.

Eligibility
Key inclusion criteria
Type 2 diabetics with microalbuminuria (30–600 mg/24 h or an albumin-to-creatinine ratio of 3.0–30 mg/mmol) with or without mildly impaired renal function (estimated GFR 40-75 ml/min/1.73m2, as calculated from serum creatinine). Able to give informed consent.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Body mass index (BMI) less than 27, unstable cardiovascular, hepatic, pulmonary disease or medical condition that would make participation in trial unsafe. Not pregnant or breastfeeding.

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)
Subjects responding to advertisements will be screened for suitability and then divided into two matched groups according to age, sex, and weight by a participant not involved medically with the trial. One group will be assigned the low glycaemic index diet and the other the high protein weight loss diet at this point. Allocation concealment has been followed in that the person responsible for the allocation schedule will be a trial manager who does not decide who is eligible for the trial and has no input into medical or dietetic decision making in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once two equal groups generated then random assignment through toss of a coin.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Given a dietary intervention, it would be impossible for dieticians and subjects to be blinded.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 348 0
5000

Funding & Sponsors
Funding source category [1] 2897 0
Government body
Name [1] 2897 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Health Sciences and Nutrition
Country [1] 2897 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Address
CSIRO Health Sciences and Nutrition
Gate 13
Kintore Avenue
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 2618 0
None
Name [1] 2618 0
Address [1] 2618 0
Country [1] 2618 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4839 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 4839 0
Gate 13
Kintore Avenue
Adelaide SA 5000
Ethics committee country [1] 4839 0
Australia
Date submitted for ethics approval [1] 4839 0
01/02/2007
Approval date [1] 4839 0
05/04/2007
Ethics approval number [1] 4839 0
06/22

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28250 0
Address 28250 0
Country 28250 0
Phone 28250 0
Fax 28250 0
Email 28250 0
Contact person for public queries
Name 11407 0
Julia Weaver
Address 11407 0
CSIRO Health Sciences and Nutrition
Gate 13
Kintore Avenue
Adelaide SA 5000
Country 11407 0
Australia
Phone 11407 0
+61 8 83038800
Fax 11407 0
Email 11407 0
[email protected]
Contact person for scientific queries
Name 2335 0
David Jesudason
Address 2335 0
CSIRO Health Sciences and Nutrition
Gate 13
Kintore Avenue
Adelaide SA 5000
Country 2335 0
Australia
Phone 2335 0
+61 8 83038800
Fax 2335 0
Email 2335 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.