Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000490572
Ethics application status
Approved
Date submitted
25/09/2006
Date registered
28/11/2006
Date last updated
23/11/2021
Date data sharing statement initially provided
22/06/2021
Date results information initially provided
22/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Diabetes Excess Weight Loss (DEWL) Trial: High Protein vs Low Fat Diets
Scientific title
Diabetes Excess Weight Loss (DEWL) Trial: High Protein vs Low Fat Diets
Secondary ID [1] 304586 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
DEWL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 1467 0
Obesity 1468 0
Condition category
Condition code
Metabolic and Endocrine 1563 1563 0 0
Diabetes
Diet and Nutrition 1564 1564 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High protein diet versus a low fat diet:
Group 2 (Intervention) “High-Protein:Reduced-Carbohydrate”: Reduced carbohydrate (40% total energy) with a focus on whole grains, low glycaemic index foods, and high fibre (30g/day). The diet will also include increased protein (30% total energy) and moderate fat (30% total energy) with a focus on Monounsaturated Fatty Acids and Polyunsaturated Fatty Acids and no more than 10% being saturated fat, aiming for a reduction in total energy intake of 500kcal/day.
All subjects will take part in a 12-month group-based programme, attending fortnightly meetings with a dietitian for the first six months to facilitate weight loss and adherence to the specific dietary protocol. This will be followed by a less intensive 6-month period with monthly sessions. Subjects will then be asked to maintain their weight loss by adhering to the dietary protocol, but will have no further dietitian input for a further 12 months, apart from monthly weighs.
Intervention code [1] 1376 0
Lifestyle
Comparator / control treatment
Group 1 (Control) Conventional- “Low-fat”: Subjects in this group will be prescribed an energy-restricted diet based on current recommended macronutrient composition. This will include 55-60% carbohydrate, with predominantly low glycaemic index, whole-grain foods with high fibre intake (30g/day), and minimal refined carbohydrates. The balance of the diet will be composed of 25-30% fat, with no more than 10% being saturated fat, and approximately 15% protein, aiming for a reduction in total energy intake of 500kcal/day.
Control group
Active

Outcomes
Primary outcome [1] 2158 0
Change in weight
Timepoint [1] 2158 0
Measured at baseline, 6 months, 12 months and 24 months
Primary outcome [2] 2159 0
Change in waist circumference
Timepoint [2] 2159 0
Measured at baseline, 6 months, 12 months and 24 months
Secondary outcome [1] 3765 0
Glycaemic control (serum HbA1c)
Timepoint [1] 3765 0
Outcome measures are assessed at baseline, 6 months, 12 months and 24 months.
Secondary outcome [2] 3766 0
Systolic and diastolic blood pressure
Timepoint [2] 3766 0
Outcome measures are assessed at baseline, 6 months, 12 months and 24 months.
Secondary outcome [3] 3767 0
Lipid profile (Total cholesterol, LDL, triglycerides, HDL)
Timepoint [3] 3767 0
Outcome measures are assessed at baseline, 6 months, 12 months and 24 months.
Secondary outcome [4] 3768 0
Dietary adherence,
Timepoint [4] 3768 0
Outcome measures are assessed at baseline, 6 months, 12 months and 24 months.
Secondary outcome [5] 3769 0
Body fatness (bio-impedance)
Timepoint [5] 3769 0
Outcome measures are assessed at baseline, 6 months, 12 months and 24 months.
Secondary outcome [6] 3770 0
Renal function
Timepoint [6] 3770 0
Outcome measures are assessed at baseline, 6 months, 12 months and 24 months.
Secondary outcome [7] 3771 0
Quality of life
Timepoint [7] 3771 0
Outcome measures are assessed at baseline, 6 months, 12 months and 24 months.

Eligibility
Key inclusion criteria
Overweight (BMI equal or greater than 27kg/m2) adults with established type 2 diabetes requiring oral antidiabetic agents and/or insulin, or are diet-controlled and meet the WHO criteria for diabetes.
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current or recent weight change (>3kg) in the previous three months, on weight-reducing medication (e.g. Orlistat or Sibutrimine), pregnancy or lactation, planning pregnancy during the timeframe of the study, an eating disorder or active psychiatric illness, serum HbA1c>9.5, diabetic nephropathy or other chronic renal failure, abnormal liver enzymes (Aspartate aminotranferase (AST), Alanine transferase (ALT) and Gamma-glutamyl transpeptidase (GGT) >3 x upper limit of normal), active gallbladder disease, heart failure (New York Heart Association class III or IV), myocardial infarction in the last six months, known malignancy within the last 5 years and not in remission, ongoing oral steroid use, or other reasons why taking part would be practically difficult (e.g. institutional care).

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)
Baseline measures completed prior to randomisation. Computer randomised sequence at a distant site and random allocation of each individual emailed to personnel independent of those assessing outcome measures. These personnel organise allocation of the individuals into the two groups according to random allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomised sequence at a distant site by independent person
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The outcome assessor is blind to allocation of randomisation
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/01/2007
Actual
20/01/2007
Date of last participant enrolment
Anticipated
Actual
26/02/2008
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
450
Accrual to date
Final
419
Recruitment outside Australia
Country [1] 23827 0
New Zealand
State/province [1] 23827 0
N/A

Funding & Sponsors
Funding source category [1] 1704 0
Government body
Name [1] 1704 0
New Zealand Health Research Council
Country [1] 1704 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Health Research Council
Address
PO Box 5541, Wellesley Street, Auckland, 1141
Country
New Zealand
Secondary sponsor category [1] 1505 0
None
Name [1] 1505 0
N/A
Address [1] 1505 0
Country [1] 1505 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3159 0
New Zealand Multi-region Ethics Committee-Wellington
Ethics committee address [1] 3159 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 3159 0
New Zealand
Date submitted for ethics approval [1] 3159 0
Approval date [1] 3159 0
01/08/2006
Ethics approval number [1] 3159 0
MEC/06/08/081
Ethics committee name [2] 3160 0
New Zealand Multi-region Ethics Committee-Hutt Valley
Ethics committee address [2] 3160 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [2] 3160 0
New Zealand
Date submitted for ethics approval [2] 3160 0
Approval date [2] 3160 0
Ethics approval number [2] 3160 0
MEC/06/08/081
Ethics committee name [3] 3161 0
New Zealand Multi-region Ethics Committee-Auckland
Ethics committee address [3] 3161 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [3] 3161 0
New Zealand
Date submitted for ethics approval [3] 3161 0
Approval date [3] 3161 0
Ethics approval number [3] 3161 0
MEC/06/08/081
Ethics committee name [4] 3162 0
New Zealand Multi-region Ethics Committee-Christchurch
Ethics committee address [4] 3162 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [4] 3162 0
New Zealand
Date submitted for ethics approval [4] 3162 0
Approval date [4] 3162 0
Ethics approval number [4] 3162 0
MEC/06/08/081

Summary
Brief summary
Reducing the incidence and impact of obesity and diabetes is a priority. Diet and lifestyle modification remains the cornerstone of management. Despite the widespread promotion of low-fat/high-carbohydrate (LFHC) diets, rates of obesity continue to climb. Short-term studies in non-diabetic subjects suggest high-protein/low-carbohydrate (HPLC) diets may facilitate greater weight-loss.
This randomised controlled trial will assess the impact of a HPLC diet compared with a LFHC diet in 450 overweight individuals with type 2 diabetes. Subjects will receive group-based and individualized dietitian support. Weight, diabetes control, cardiovascular disease risk, adverse effects and cost-effectiveness will be assessed over 24 months.
Demonstration that a HPLC diet is effective and cost-effective without significant adverse effects in subjects with diabetes would have a wide-ranging impact for individual and public health advice both in New Zealand and internationally.
Trial website
Trial related presentations / publications
KREBS JD, ELLEY CR, PARRY-STRONG A, LUNT H, DRURY PL, BELL DA, ROBINSON E, MOYES SA, MANN JI, Diabetes Excess Weight Loss (DEWL) Trial: A Randomised Controlled Trial of High-Protein versus High Carbohydrate Diets over 2 years in Type 2 Diabetes Diabetologia 2012, 55, (4), 905-914, DOI 10.1007/s00125-012-2461-0
Public notes

Contacts
Principal investigator
Name 27603 0
Dr Jeremy Krebs
Address 27603 0
Department of Medicine Wellington School of Medicine and Health Sciences University of Otago PO Box 7343 Wellington South
Country 27603 0
New Zealand
Phone 27603 0
+64 4 3855999
Fax 27603 0
Email 27603 0
Jeremy.krebs@ccdhb.org.nz
Contact person for public queries
Name 10565 0
Dr Dr Jeremy Krebs
Address 10565 0
Department of Medicine
Wellington School of Medicine and Health Sciences
University of Otago
PO Box 7343
Wellington South
Country 10565 0
New Zealand
Phone 10565 0
+64 4 3855999
Fax 10565 0
+64 4 3855819
Email 10565 0
Jeremy.krebs@ccdhb.org.nz
Contact person for scientific queries
Name 1493 0
A/Prof Dr C. Raina Elley
Address 1493 0
Department of General Practice and Primary Health Care
School of Population Health
University of Auckland
Private Bag 91219
Auckland
Country 1493 0
New Zealand
Phone 1493 0
+64 9 3737599
Fax 1493 0
+64 9 3737624
Email 1493 0
c.elley@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.