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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Insulin Resistance

Intervention / Treatment
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* Behavioral: moderate carbohydrate, high protein diet (MCHP)
* Behavioral: high carbohydrate-high fibre (HCHF) diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: moderate carbohydrate, high protein diet (MCHP)|nan|
|Behavioral: high carbohydrate-high fibre (HCHF) diet|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake as measured by 3-day weight diet records |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maori, insulin sensitivity, cardiovascular risk, diabetes prevention, diet modification