Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000383561
Ethics application status
Approved
Date submitted
25/02/2015
Date registered
27/04/2015
Date last updated
24/02/2020
Date data sharing statement initially provided
24/02/2020
Date results provided
24/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of intermittent compared to continuous energy restriction in type 2 diabetes
Scientific title
The effects of intermittent compared to continuous energy restriction on weight and glycaemic control in type 2 diabetes
Secondary ID [1] 286024 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 293996 0
Condition category
Condition code
Diet and Nutrition 294290 294290 0 0
Obesity
Metabolic and Endocrine 294726 294726 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intermittent energy restriction (IER), type 2 diabetes, 12 months. IER is any short period where energy is restricted. For the purpose of this trial energy will be restricted using a very low calorie approach 500/600kcals/day, for two consecutive days/week - fasting days. Ad librium eating will be followed for the remaining 5 days/week - non-fasting days. Calorie advice will be provided for the fasting days with both serve suggestion and example meal plans and compliance will be monitored via food diaries at fortnightly visits for the first 3 months and then monthly visits thereafter with the study dietitian.
Intervention code [1] 291007 0
Treatment: Other
Comparator / control treatment
Continuous energy restriction (CER), type 2 diabetes, 12 months. CER refers to the standard method of energy restriction used for weight loss. For the purpose of this trial CER will be limiting daily caloric intake to 1200-1700kcals/day. Calorie advice will be provided via serve suggestion and example meal plans and compliance will be monitored via food diaries at fortnightly visits for the first 3 months and then monthly visits thereafter with the study dietitian.
Control group
Active

Outcomes
Primary outcome [1] 294093 0
HbA1c measured using HbA1c point of care machine.
Timepoint [1] 294093 0
Baseline, 3 and 12 months with a maintenance follow-up visit at 2 years.
Secondary outcome [1] 312503 0
Weight measured using calibrated digital scales.
Timepoint [1] 312503 0
Baseline, 3 and 12 months with a maintenance follow-up visit at 2 years.
Secondary outcome [2] 313234 0
Body composition measured by DEXA
Timepoint [2] 313234 0
Baseline, 3 and 12 months with a maintenance follow-up visit at 2 years.
Secondary outcome [3] 313235 0
Lipids measured via blood sample.
Timepoint [3] 313235 0
Baseline, 3 and 12 months with a maintenance follow-up visit at 2 years.
Secondary outcome [4] 313236 0
Fasting blood glucose
Timepoint [4] 313236 0
Baseline, 3 and 12 months with a maintenance follow-up visit at 2 years.

Eligibility
Key inclusion criteria
Aged >18yrs
Type 2 Diabetes
BMI >27kg/m2
Not pregnant or breast feeding
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Weight loss surgery, ongoing weight loss studies or weight loss of 4.5kg or more in past 3mths
Blood pressure >160/100 mm Hg
Women who are pregnant or breast feeding or wish to become pregnant
Cancer currently under active treatment
Active liver or kidney disease

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)
Following initial contact with the university potential subjects will be screened and randomly allocated to one of the arms of the study. Participants will be stratified according to gender, BMI and age before randomisation. A random number block randomization will be used. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random balanced number sequence generator (randomization.com)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures analysis of variance will be used.

Participant numbers are an estimate only as there are no previous studies in people with type 2 diabetes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/04/2015
Actual
6/04/2015
Date of last participant enrolment
Anticipated
30/06/2016
Actual
30/09/2016
Date of last data collection
Anticipated
30/10/2018
Actual
2/11/2018
Sample size
Target
100
Accrual to date
Final
137
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 9285 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 290616 0
University
Name [1] 290616 0
University of South Australia
Country [1] 290616 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
School of Pharmacy and Medical Sciences
GPO Box 2471 Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 289302 0
None
Name [1] 289302 0
Address [1] 289302 0
Country [1] 289302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292246 0
University of South Australia
Ethics committee address [1] 292246 0
Ethics committee country [1] 292246 0
Australia
Date submitted for ethics approval [1] 292246 0
Approval date [1] 292246 0
02/03/2015
Ethics approval number [1] 292246 0

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

Contacts
Principal investigator
Name 54294 0
A/Prof Jennifer Keogh
Address 54294 0
Playford Building Office P1-23
City East Campus, Frome Road
School of Pharmacy and Medical Sciences
University of South Australia
Adelaide SA 5000

Postal address: GPO Box 2471 Adelaide SA 5000
Country 54294 0
Australia
Phone 54294 0
+61 8 83022579
Fax 54294 0
Email 54294 0
jennifer.keogh@unisa.edu.au
Contact person for public queries
Name 54295 0
Jennifer Keogh
Address 54295 0
Playford Building Office P1-23
City East Campus, Frome Road
School of Pharmacy and Medical Sciences
University of South Australia
Adelaide SA 5000

Postal address: GPO Box 2471 Adelaide SA 5000
Country 54295 0
Australia
Phone 54295 0
+61 8 83022579
Fax 54295 0
Email 54295 0
jennifer.keogh@unisa.edu.au
Contact person for scientific queries
Name 54296 0
Jennifer Keogh
Address 54296 0
Playford Building Office P1-23
City East Campus, Frome Road
School of Pharmacy and Medical Sciences
University of South Australia
Adelaide SA 5000

Postal address: GPO Box 2471 Adelaide SA 5000
Country 54296 0
Australia
Phone 54296 0
+61 8 83022579
Fax 54296 0
Email 54296 0
jennifer.keogh@unisa.edu.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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 2018 https://jamanetwork.com/journals/jamanetwo... [More Details] 367809-(Uploaded-18-02-2020-11-54-36)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of intermittent compared with continuous energy restriction on glycaemic control in patients with type 2 diabetes: 24-month follow-up of a randomised noninferiority trial.2019https://dx.doi.org/10.1016/j.diabres.2019.03.022
N.B. These documents automatically identified may not have been verified by the study sponsor.