Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000492257
Ethics application status
Approved
Date submitted
16/06/2009
Date registered
19/06/2009
Date last updated
19/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Weight loss and type 2 diabetes study 2009
Scientific title
A 12 month parallel study comparing generic weight loss advice versus meal replacement on weight loss in overweight people with type 2 diabetes
Universal Trial Number (UTN)
Trial acronym
MR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity and diabetes 237037 0
Condition category
Condition code
Diet and Nutrition 237361 237361 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Overweight subjects with type 2 diabetes will be randomized to either a generic weight loss advice group or they will be randomized to a meal replacement group.The weight loss advice group will be attending a group information session at the start of the study. That group will be asked to follow that advice for 12 months.The meal replacement group will consume 2 meal replacements/day until a weight loss of 10% is achieved and will then switch to one meal replacement/day, for a total trial duration of 12 months.The product will be manufactured by Probiotec..
Intervention code [1] 236765 0
Lifestyle
Comparator / control treatment
Overweight subjects with type 2 diabetes will be given an information book on diet and lifestyle and asked to follow dietary advice provided within this book for the duration of the study which is 12 months. No professional advice will be provided other than one hours introductory group session at the start of the study.
Control group
Active

Outcomes
Primary outcome [1] 238167 0
The primary outcomes are weight, body composition (fat distribution) measured by dual energy X-ray absorptiometry and Glycosylated haemoglobin (HbA1c).
Timepoint [1] 238167 0
Baseline at 3 months and at 12 months
Secondary outcome [1] 242449 0
Clinically monitor fasting lipids and glucose, by blood analysis and blood pressure measurements.
Timepoint [1] 242449 0
Baseline at 3 months and at 12 months

Eligibility
Key inclusion criteria
Body Mass Index greater than27.
Weight limit of 130kg.
Type 2 diabetes diet controlled, on oral hypoglycaemic medication or on insulin.
HbA1c less than 9%
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known lactose intolerance or dairy allergy .
Participation in a study within 30 days of commencement of the study.
Weight changes of more than 3kg over last 3 months.
Taking any medications which may interfere with study parameters.
Untreated hypertension
Systolic Blood Pressure more than 150 mmHg.
Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
27/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237161 0
Commercial sector/Industry
Name [1] 237161 0
Probiotec Limited
Country [1] 237161 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Probiotec Limited
Address
83 Cherry Lane
Laverton North
VICTORIA
3026
Country
Australia
Secondary sponsor category [1] 4650 0
None
Name [1] 4650 0
Address [1] 4650 0
Country [1] 4650 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 29749 0
Address 29749 0
Country 29749 0
Phone 29749 0
Fax 29749 0
Email 29749 0
Contact person for public queries
Name 12996 0
Julia Weaver
Address 12996 0
CSIRO Human Nutrition
Gate 13
Kintore Ave
Adelaide SA 5000
Country 12996 0
Australia
Phone 12996 0
+61 83038876
Fax 12996 0
+61 83038899
Email 12996 0
[email protected]
Contact person for scientific queries
Name 3924 0
Dr Peter Clifton
Address 3924 0
CSIRO Human Nutrition
Gate 13
Kintore Ave
Adelaide SA 5000
Country 3924 0
Australia
Phone 3924 0
+61 83038826
Fax 3924 0
+61 83038899
Email 3924 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.