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Measures of Obesity and Co-Morbid Conditions in Maori

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00208598
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Edgar National Centre for Diabetes Research
  Purpose
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.

Condition
Body Composition

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective

Further study details as provided by Edgar National Centre for Diabetes Research:

Estimated Enrollment: 220
Study Start Date: January 2003
Estimated Study Completion Date: December 2005
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208598


Locations
New Zealand
Edgar National Centre for Diabetes Research
Dunedin, Otago, New Zealand, 9001
Sponsors and Collaborators
Edgar National Centre for Diabetes Research
Investigators
Study Director: Jim I Mann, FRACP, PhD Edgar National Centre for Diabetes Research
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00208598     History of Changes
Other Study ID Numbers: ENCDR_3
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Edgar National Centre for Diabetes Research:
Maori
Body Composition
DEXA
Cardiovascular disease
Diabetes