He Purongo Mo Nga Kai Hei Arai i Te Matehuka – Dietary Diabetes Prevention Study for Maori

This study has been completed.
Sponsor:
Information provided by:
Edgar National Centre for Diabetes Research
ClinicalTrials.gov Identifier:
NCT00208637
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 13, 2005
September 13, 2005
August 2002
Not Provided
Dietary intake as measured by 3-day weight diet records
Same as current
No Changes Posted
  • Blood pressure
  • Bioelectric Impedence
  • Weight
  • Waist circumference
  • Total cholesterol and lipid subfractions (LDL, HDL)
  • Fasting insulin
  • Lipoprotein A + B
  • Inflammatory markers
  • Urinary albumin:creatinine ratio
  • Quality of life
  • All measures to be compared at end of study (6 months)
Same as current
Not Provided
Not Provided
 
He Purongo Mo Nga Kai Hei Arai i Te Matehuka – Dietary Diabetes Prevention Study for Maori
Not Provided

High protein diets are popular among Maori, especially on the East Coast of the North Island. The purpose of this study was to compare the metabolic effects of a moderate carbohydrate, high protein diet (MCHP) with a high carbohydrate-high fibre (HCHF) diet on insulin sensitivity in Maori at increased risk of developing diabetes and cardiovascular disease.

This was a 6-month pilot intervention study of self-identifying Maori participants in a randomised control trial conducted in Dunedin and Invercargill. The study consisted of three, two month phases and was conducted over a period of six months. Participants meeting all the inclusion criteria were randomised into three groups: moderate carbohydrate-high protein (MCHP), high carbohydrate-high fibre (HCHF) or a control group. Those randomised to the experimental diets were recommended an energy intake based on their current BMI levels. The aim of phase one was to achieve weight loss with weekly advice and support from the research team. The aim of phase two was for weight maintenance with continued weekly advice and support. Phase three consisted of a weight maintenance phase without support. Those in the control group were instructed to follow their own self selected diet plan.

Outcome was determined by examining surrogate clinical endpoints. The clinical endpoints included the following recorded measurements of anthropometric measurements, bioelectrical impedance measurements, profile of mood state questionnaires, activity questionnaires, and three day diet records were collected at 0, 2, 4 and 6 month periods. Biochemical measures of lipid profile, fasting insulin and glucose, liver functions and uric acid levels were also conducted.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Insulin Resistance
  • Behavioral: moderate carbohydrate, high protein diet (MCHP)
  • Behavioral: high carbohydrate-high fibre (HCHF) diet
Not Provided
Brooking LA, Williams SM, Mann JI. Effects of macronutrient composition of the diet on body fat in indigenous people at high risk of type 2 diabetes. Diabetes Res Clin Pract. 2012 Apr;96(1):40-6. doi: 10.1016/j.diabres.2011.11.021. Epub 2011 Dec 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2004
Not Provided

Inclusion Criteria:

  • Self identify as Maori aged between 17-75 years
  • Male and female
  • Non-diabetic
  • Resident of Dunedin and Invercargill
  • BMI >27
  • Family history of T2D

Exclusion Criteria:

  • The presence of diabetes, renal or liver failure, or any other medical condition which is unstable and for which potential partcipants are currently having active treatment.
Both
17 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT00208637
Kai Study
Not Provided
Not Provided
Edgar National Centre for Diabetes Research
Not Provided
Principal Investigator: Lorraine Brooking, BSc, MA Edgar National Centre for Diabetes Research, Dunedin, NZ
Study Director: Jim I Mann, FRACP, PhD Edgar National Centre for Diabetes Research, Dunedin, NZ
Edgar National Centre for Diabetes Research
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP