Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001301156p
Ethics application status
Submitted, not yet approved
Date submitted
15/08/2019
Date registered
23/09/2019
Date last updated
23/09/2019
Date data sharing statement initially provided
23/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a very low calorie diet (VLCD) induce remission in people with Type 2 diabetes?
Scientific title
Very Low Calorie Diet (VLCD) and Lifestyle Modification Program for Remission of Type 2 Diabetes Mellitus: A Prospective, Open-label Intervention Study
Secondary ID [1] 299034 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 314047 0
Condition category
Condition code
Metabolic and Endocrine 312436 312436 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 participants will commence a very low calorie diet (VLCD) meal replacement for 3 months with a gradual re-introduction back to a healthy diet over a 12 month period. Participants will be required to purchase VLCD for the first month at a reduced cost of 25% of the retail cost. Thereafter, participants will be supplied with their VLCD free of charge. Participants will also attend 4 group education sessions on diabetes, diet and healthy lifestyle education. Participants will attend outpatient clinic appointments at set intervals with an Endocrinologist, diabetes nurse and dietitian. Blood tests will be required 3 monthly until the end of the 12 month trial.
VLCD is defined as approx. 800 calories per day
Participants will be on VLCD meal replacement for 12 weeks. The following 4 weeks participants will be on approx. 1000 calories a day. This diet will be comprised of 2 VLCD meal replacements and 1 normal food meal
The following 4 weeks after that people will be on 1 VLCD meal replacement and 2 normal food meals approx. 1200 calories per day. After this patients will be on normal healthy eating for 3 meals per day as per the dietitian recommendations related to calorie intake. The VLCD meal replacement will be Optislim Platinum VLCD.
Participants will be weighed every 2 weeks during the initial phase, if there is weight gain people will be offered additional apt with dietitian for adherence strategies
Group education will be the QLD health approved HELP program which is around healthy eating and physical activity. The diabetes nurse educators and dietitian will run the sessions in a meeting room setting. There will be approx. 5 participants per group. There will be 4 x 2hr group sessions in total occurring in the first 8 weeks of the participant commencing VLCD. It will be documented if participants don't attend. They will be offered 'catch up' sessions as sessions will be running regularly
Intervention code [1] 315307 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321144 0
Change in HbA1c as evidenced by serum assay
Timepoint [1] 321144 0
At 12 months post intervention
Secondary outcome [1] 373918 0
Change in weight by 10kg or more as assessed by measuring weight at 12 month appointment on a digital scale
Timepoint [1] 373918 0
At 12 months post intervention
Secondary outcome [2] 374339 0
Change in hypertension as evidenced by comparing measurements pre and post study at 12 months using an automated sphygmomanometer
Timepoint [2] 374339 0
At 12 months post intervention
Secondary outcome [3] 374340 0
change in renal function as assessed by serum assay and urine assay
serum albumin, creatinine and eGFR
urine albumin creatinine ratio
Timepoint [3] 374340 0
at 12 months post intervention
Secondary outcome [4] 374341 0
change in cholesterol as assessed by serum assay
Timepoint [4] 374341 0
at 12 months post intervention

Eligibility
Key inclusion criteria
1. 18 – 65 years of age
2. Able to provide informed consent
3. Duration of type 2 diabetes of less than 6 years.
4. HbA1c > than 6.5%
5. BMI >27kg/m2
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Recent eGFR <30mls/min/1.73m2
2. Severe hepatic impairment
3. Alcohol or illegal substance dependence
4. Known cancer
5. Myocardial infarction within previous 6 months
6. Severe heart failure defined as equivalent to the NYHA grade 3
7. Diagnosed eating disorder or purging
8. Pregnancy and breastfeeding
9. Patients on insulin therapy
10. Patients on anti-obesity medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 303568 0
Government body
Name [1] 303568 0
Health Innovation, Investment and Research Office
Country [1] 303568 0
Australia
Primary sponsor type
Individual
Name
Kathy Harrison
Address
Princess Alexandra Hospital | Metro South Health
Level 1, Burke Street Centre | 2 Burke Street, Woolloongabba Qld 4102
Country
Australia
Secondary sponsor category [1] 303647 0
Individual
Name [1] 303647 0
Dr Viral Chikani
Address [1] 303647 0
Princess Alexandra Hospital | Metro South Health
Level 1, Burke Street Centre | 2 Burke Street, Woolloongabba Qld 4102
Country [1] 303647 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304099 0
Metro South Hospital & Health Service - Metro South Human Research Ethics Committee
Ethics committee address [1] 304099 0
Ethics committee country [1] 304099 0
Australia
Date submitted for ethics approval [1] 304099 0
16/08/2019
Approval date [1] 304099 0
Ethics approval number [1] 304099 0

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

Contacts
Principal investigator
Name 95806 0
Ms Kathy Harrison
Address 95806 0
Princess Alexandra Hospital | Metro South Health
Level 1, Burke Street Centre | 2 Burke Street, Woolloongabba Qld 4102
Country 95806 0
Australia
Phone 95806 0
+61 7 31761060
Fax 95806 0
Email 95806 0
[email protected]
Contact person for public queries
Name 95807 0
Kathy Harrison
Address 95807 0
Princess Alexandra Hospital | Metro South Health
Level 1, Burke Street Centre | 2 Burke Street, Woolloongabba Qld 4102
Country 95807 0
Australia
Phone 95807 0
+61 7 31761060
Fax 95807 0
Email 95807 0
[email protected]
Contact person for scientific queries
Name 95808 0
Kathy Harrison
Address 95808 0
Princess Alexandra Hospital | Metro South Health
Level 1, Burke Street Centre | 2 Burke Street, Woolloongabba Qld 4102
Country 95808 0
Australia
Phone 95808 0
+61 7 31761060
Fax 95808 0
Email 95808 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All De-identified outcome data will be available.
When will data be available (start and end dates)?
No start or end date determined until ethics approval
Available to whom?
Discretion of investigator
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator
Kathy Harrison and Viral Chikani
via email [email protected]


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.