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Trial registered on ANZCTR


Registration number
ACTRN12607000133437
Ethics application status
Not yet submitted
Date submitted
16/02/2007
Date registered
19/02/2007
Date last updated
19/02/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Differences in weight loss using a very low energy diet in obese people with and without diabetes.
Scientific title
In obese subjects with and without diabetes, examining the effect of a very low energy diet (VLED) on weight loss and differences in changes in cardiovascular risk, markers of oxidative stress and advanced glycation, and target organ function.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 1625 0
Diabetes 1626 0
Condition category
Condition code
Diet and Nutrition 1733 1733 0 0
Obesity
Metabolic and Endocrine 1734 1734 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A very low energy diet (Optifast). This is a meal replacement diet involving three sachets daily plus one serve of vegetables or salad (600-800kcal/day) for 12 weeks (intensive phase). Subsequently patients are weaned over 8 weeks onto a calorie controlled CSIRO-type diet.
Intervention code [1] 1608 0
Lifestyle
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2408 0
Change in body composition
Timepoint [1] 2408 0
At 24 weeks
Primary outcome [2] 2409 0
Change in markers of oxidative stress
Timepoint [2] 2409 0
At 24 weeks
Primary outcome [3] 2410 0
Change in markers of advanced glycation
Timepoint [3] 2410 0
At 24 weeks
Primary outcome [4] 2411 0
Change in target organ function
Timepoint [4] 2411 0
At 24 weeks
Secondary outcome [1] 4187 0
Difference in weight loss
Timepoint [1] 4187 0
At 24 weeks

Eligibility
Key inclusion criteria
BMI 30 - 50 kg/m2, diabetes and no diabetes.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Thiazolidinedione therapy, significant comorbidity, previously failed VLED or bariatric surgery.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1883 0
Commercial sector/Industry
Name [1] 1883 0
Pfizer CVL grant
Country [1] 1883 0
Funding source category [2] 1884 0
Hospital
Name [2] 1884 0
Austin Endocrine Centre research fund
Country [2] 1884 0
Australia
Primary sponsor type
Individual
Name
George Jerums
Address
Country
Secondary sponsor category [1] 1698 0
Individual
Name [1] 1698 0
Joseph Proietto
Address [1] 1698 0
Country [1] 1698 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3507 0
Austin Health
Ethics committee address [1] 3507 0
Ethics committee country [1] 3507 0
Australia
Date submitted for ethics approval [1] 3507 0
Approval date [1] 3507 0
Ethics approval number [1] 3507 0

Summary
Brief summary
Obesity and type 2 diabetes increase the risk of heart, kidney and other disease. A process called oxidative stress is thought to be critical in triggering metabolic changes found in both obesity and diabetes, and thus is a major cause of developing complications from these conditions. The role of weight loss in reducing markers of oxidative stress has not been compared in obese people with and without diabetes. We predict that weight loss in obese patients with diabetes will reduce oxidative stress, and improve kidney and heart dysfunction, to a greater extent than in obese patients without diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27542 0
Address 27542 0
Country 27542 0
Phone 27542 0
Fax 27542 0
Email 27542 0
Contact person for public queries
Name 10797 0
Dr Scott Baker
Address 10797 0
Endocrine Centre
Centaur Wing Repatriation Campus
Austin Health
Waterdale Rd, West Heidelberg 3081
Country 10797 0
Australia
Phone 10797 0
03 9496 5489
Fax 10797 0
03 9496 3365
Email 10797 0
[email protected]
Contact person for scientific queries
Name 1725 0
Professor George Jerums
Address 1725 0
Endocrine Centre
Centaur Wing Repatriation Campus
Austin Health
Waterdale Rd, West Heidelberg VIC 3081
Country 1725 0
Australia
Phone 1725 0
03 9496 5489
Fax 1725 0
03 9496 3365
Email 1725 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.