Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00208598




Registration number
NCT00208598
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
21/09/2005

Titles & IDs
Public title
Measures of Obesity and Co-Morbid Conditions in Maori
Scientific title
Secondary ID [1] 0 0
ENCDR_3
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body Composition 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Self identify as Maori and non-Maori aged between 18-68 years
* Male and female
* Non-diabetic
* Resident of Dunedin and Invercargill
Minimum age
18 Years
Maximum age
68 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* The presence of diabetes, renal or liver failure, or any other medical condition which is unstable and for which they are currently having active treatment

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Otago

Funding & Sponsors
Primary sponsor type
Other
Name
Edgar National Centre for Diabetes Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
It has been proposed that a higher cut off for BMI (body mass index) is to be used in Maori to define overweight and obesity. However, no one has assessed the prevalence of co-morbid conditions associated with BMI. It is well known that Maori are at greater risk of diabetes and cardiovascular disease compared to non-Maori and a delay in the identification of those who are overweight and obese may be detrimental for Maori. We will assess BMI, other measures of adiposity and prevalence of co-morbid conditions with a comparison with a similar matched non-Maori population.
Trial website
https://clinicaltrials.gov/study/NCT00208598
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jim I Mann, FRACP, PhD
Address 0 0
Edgar National Centre for Diabetes Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00208598