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NCT00208598 Clinical Trial

Measures of Obesity and Co-Morbid Conditions in Maori

Body Composition Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00208598
Other study ID # ENCDR_3
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated September 13, 2005
Start date January 2003
Est. completion date December 2005

Study information
Verified date September 2005
Source Edgar National Centre for Diabetes Research
Contact n/a
Is FDA regulated No
Health authority New Zealand: Health and Disability Ethics Committees
Study type Observational

Clinical Trial 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.

Description:

This is a body composition analysis study of people self-identifying Maori and non-Maori participants from both Dunedin and Invercargill. The study consists of a clinical visit for anthropometry and oral glucose tolerance test (OGTT), followed by a single Dexa Scan visit. Participants meeting all the inclusion criteria were invited to participate in the study.

Outcome will be determined by examining Dexa Scan data and surrogate clinical endpoints. The clinical endpoints include: anthropometric measurements, Dexa analysis, bioelectric impedance, and BP measurements, and the biochemical measures of: lipid profile, fasting insulin and glucose, liver functions and uric acid levels.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 68 Years
Eligibility Inclusion Criteria:

- Self identify as Maori and non-Maori aged between 18-68 years

- Male and female

- Non-diabetic

- Resident of Dunedin and Invercargill

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

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
New Zealand Edgar National Centre for Diabetes Research Dunedin Otago

Sponsors (1)
Lead Sponsor Collaborator
Edgar National Centre for Diabetes Research

Country where clinical trial is conducted

New Zealand, 

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