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

NCT ID: NCT00208637

Last Updated: 2005-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-12-31

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

Keywords

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Maori insulin sensitivity cardiovascular risk diabetes prevention diet modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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moderate carbohydrate, high protein diet (MCHP)

Intervention Type BEHAVIORAL

high carbohydrate-high fibre (HCHF) diet

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Edgar National Centre for Diabetes Research

OTHER

Sponsor Role lead

Principal Investigators

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Lorraine Brooking, BSc, MA

Role: PRINCIPAL_INVESTIGATOR

Edgar National Centre for Diabetes Research, Dunedin, NZ

Jim I Mann, FRACP, PhD

Role: STUDY_DIRECTOR

Edgar National Centre for Diabetes Research, Dunedin, NZ

Locations

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Edgar National Centre for Diabetes Research

Dunedin, Otago, New Zealand

Site Status

Countries

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New Zealand

References

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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.

Reference Type DERIVED
PMID: 22178004 (View on PubMed)

Related Links

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http://www.otago.ac.nz/diabetes

Edgar National Centre for Diabetes Research, NZ website

Other Identifiers

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Kai Study

Identifier Type: -

Identifier Source: org_study_id