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Trial registered on ANZCTR


Registration number
ACTRN12614000567628
Ethics application status
Approved
Date submitted
22/05/2014
Date registered
28/05/2014
Date last updated
15/09/2024
Date data sharing statement initially provided
15/10/2021
Date results provided
15/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The 5:2 Diet Study to Treat Overweight Patients with diabetes
Scientific title
Effect of the 5:2 Diet versus a Calorie Restriction dietary intervention on change in HbA1c in overweight patients with Type 1 and Type 2 Diabetes
Secondary ID [1] 284643 0
Nil
Universal Trial Number (UTN)
Trial acronym
The 5:2 STOP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 291958 0
Obesity 291959 0
Condition category
Condition code
Metabolic and Endocrine 292310 292310 0 0
Diabetes
Diet and Nutrition 292311 292311 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: 5:2 Diet – 2 consecutive days per week of calorie reduction to 600 calories per day (Optifast Registered Trademark meal replacement for the 3 main meal a day) followed by 5 days of eating to appetite.

Arm 2: Calorie Restriction Diet – moderate (30%) reduction of calories based on baseline energy requirements. This will be calculated for each participant using their weight, height, age, gender and will follow current Australian Dietary Guidelines. The advise will be provided in a 1 hour session with a Registered Nurse at baseline. an example meal plan will be provided which will outline the breakdown of food serves. This will be based on the entries provided in a Food and Activity Diary which will be completed between the Screening and Randomisation visit.


Participants from both groups will be monitored for hypoglycaemia, ketoacidosis and diabetes treatment will be adjusted as required by the Research team.

Both diets will be followed for a 12 week period.

During the treeatment period, adherence to the study diets will be monitored by way of a Food and Activity Diary which will be completed prior to each face-to-face study visit.
Intervention code [1] 289428 0
Lifestyle
Intervention code [2] 289447 0
Treatment: Other
Comparator / control treatment
Calorie Restriction Diet – moderate (30%) reduction of calories based on baseline energy requirements. This will be calculated for each participant using their weight, height, age, gender and will follow current Australian Dietary Guidelines.
Control group
Active

Outcomes
Primary outcome [1] 292176 0
Primary Outcome 1: The change in HbA1c assessed by high-performance liquid chromatography.
Timepoint [1] 292176 0
Timepoint: One year after randomisation with an interim analysis occurring at 13 weeks (ends of active intervention).
Secondary outcome [1] 308362 0
Secondary Outcome: The change in weight

Bodyweight measurements will be taken in the fasted state to the nearest 0.1kg in light clothing and without shoes using standard scales.

Waist circumference will be measured at each face to face study visit using a flexible tape, midway between the lower costal margin and super iliac crest during a period of expiration. Measurement will be recorded to the nearest 0.1cm.

Fat mass, free fat mass and energy expenditure will be measured in the fasted state at Baseline and Weeks 13 and 52. Fat mass and free fat mass will be assessed by dual energy X-ray absorptiometry (DEXA).
Timepoint [1] 308362 0
Timepoint: One year after randomisation with an interim analysis occurring at 13 weeks (ends of active intervention).
Secondary outcome [2] 308407 0
Secondary Outcome: The change in macrovascular risk factor profile (lipids, blood pressure)

Blood pressure will be measured during these visits in a sitting position, after 5 minutes of rest, using a standard syphygmomanometer. Two readings will be taken and the mean result recorded.

Bloods will be collected to assess the lipid profile.
Timepoint [2] 308407 0
Timepoint: One year after randomisation with an interim analysis occurring at 13 weeks (ends of active intervention).

Eligibility
Key inclusion criteria
- Type 1 or Type 2 Diabetes
- Currently aged 18 years or older
- Duration of diabetes > 1 year and familiar with diabetes self management principles
- BMI between 25 and 35 kg/m2 or presence of the metabolic syndrome as defined by the International Diabetes Federation*
*Waist circumference > 94 cm for Europid men and > 80 cm for Europid women, plus any two of the following four factors:
~ Triglyceride level >1.7 mmol/L (or specific treatment)
~ HDL cholesterol < 1.03 mmol/L in males and < 1.29 mmol/L in females (or specifc treatment)
~ Systolic blood pressure > 130 mmHg
~Diastolic blood pressure > 85 mmHg (or treatment of previously diagnoses hypertension)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- HbA1c < 6.5% and > 10%
- History of unconscious hypoglycaemia or diabetic ketoacidosis within the last 12 months
- Known autonomic failure, hypoglycaemia unawareness, CVD, severe renal disease (eGFR < 30ml/min/BSA) and severe hepatic disease (synthetic dysfunction of LFT > 4 times ULN)
- Use of steroids
- Pregnancy or lactation
- Documented history of eating disorder
- Curernt treatment requires the use of pre-mixed insulin regimens

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)
At randomisation, patients will be allocated to a study (ID) number which will be used for the duration of the study. Study (ID) numbers will be sequential so the recruited patients will receive the next available patient number (eg. 1000, 1001, etc). Participants will then be randomly assigned to one of the two study arms using a random allocation table. This table will be developed before commencement of the study. The allocation will involve contacting the holder of the allocation scedule who will be "off site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation 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
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data analyses will be performed using the SPSS statistical software package.

The primary endpoint of the study was the change in HbA1c from Baseline to Week 13. Change from Baseline will be analysed using a normal linear regression model with treatment, and baseline HbA1c as covariate. A non inferiority limit of 0.4% will be applied. A sample size was calculated assuming difference of 0.4% HbA1c between groups at 12 months (7.4% vs 7.0%) with a standard deviation of 1.0% with an alpha of 5.0% and a beta of 80.0%.

ANOVA will be used to compare all patients on IF and CR diet with respect to changes in parameters of glycaemic control body-composition, neuroendocrine and gut hormone levels, cardio-metabolic health and similarly the number of hypoglycaemic episodes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/06/2014
Actual
10/09/2014
Date of last participant enrolment
Anticipated
16/06/2015
Actual
6/05/2016
Date of last data collection
Anticipated
Actual
12/07/2017
Sample size
Target
20
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2490 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 8134 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 289268 0
Hospital
Name [1] 289268 0
Department of Endocrinology, Royal Prince Alfred Hospital
Country [1] 289268 0
Australia
Funding source category [2] 289269 0
Commercial sector/Industry
Name [2] 289269 0
NovoNordisk Pty Ltd
Country [2] 289269 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Jencia Wong
Address
Level 6 West Wing
Department of Endocrinology
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 287941 0
None
Name [1] 287941 0
Address [1] 287941 0
Country [1] 287941 0
Other collaborator category [1] 277961 0
Individual
Name [1] 277961 0
Clinical Associate Professor Jane Overland
Address [1] 277961 0
Level 6 West Wing
Diabetes Centre
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country [1] 277961 0
Australia
Other collaborator category [2] 277962 0
Individual
Name [2] 277962 0
Associate Professor Amanda Salis
Address [2] 277962 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
G86 Medical Foundation Building K25
92-94 Parramatta Road
The University of Sydney
Camperdown
NSW 2006
Country [2] 277962 0
Australia
Other collaborator category [3] 277963 0
Individual
Name [3] 277963 0
Dr Tanya Little
Address [3] 277963 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
G86 Medical Foundation Building K25
92-94 Parramatta Road
The University of Sydney
Camperdown
NSW 2006
Country [3] 277963 0
Australia
Other collaborator category [4] 277964 0
Individual
Name [4] 277964 0
Dr Janet Franklin
Address [4] 277964 0
Metabolism and Obesity Service
Royal Prince Alfred Hospital
Level 6 West
Missenden Road
Camperdown
NSW 2050
Country [4] 277964 0
Australia
Other collaborator category [5] 277965 0
Individual
Name [5] 277965 0
Ms Alice Gibson
Address [5] 277965 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
G86 Medical Foundation Building K25
92-94 Parramatta Road
The University of Sydney
Camperdown
NSW 2006
Country [5] 277965 0
Australia
Other collaborator category [6] 277966 0
Individual
Name [6] 277966 0
Ms Krisztina Toth
Address [6] 277966 0
Endocrinology and Metabolism
Level 6 West Wing
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country [6] 277966 0
Australia
Other collaborator category [7] 277967 0
Individual
Name [7] 277967 0
Amanda Gauld
Address [7] 277967 0
Level 6 West Wing
Diabetes Centre
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country [7] 277967 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291040 0
Sydney Local health District - Ethics Review Committeee (RPAH Zone)
Ethics committee address [1] 291040 0
Ethics committee country [1] 291040 0
Australia
Date submitted for ethics approval [1] 291040 0
09/04/2014
Approval date [1] 291040 0
26/06/2014
Ethics approval number [1] 291040 0
X14-0015

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

Contacts
Principal investigator
Name 48594 0
A/Prof Jane Overland
Address 48594 0
Diabetes Centre
Level 6 West
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 48594 0
Australia
Phone 48594 0
+61 2 9515 5888
Fax 48594 0
Email 48594 0
jane.overland@email.cs.nsw.gov.au
Contact person for public queries
Name 48595 0
Jencia Wong
Address 48595 0
Diabetes Centre
Level 6 West
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 48595 0
Australia
Phone 48595 0
+61 2 9515 5888
Fax 48595 0
Email 48595 0
jencia.wong@email.cs.nsw.gov.au
Contact person for scientific queries
Name 48596 0
Jencia Wong
Address 48596 0
Diabetes Centre
Level 6 West
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 48596 0
Australia
Phone 48596 0
+61 2 9515 5888
Fax 48596 0
Email 48596 0
jencia.wong@email.cs.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.