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

Sponsor

Edgar National Centre for Diabetes Research (Other)

Overall Status

Completed

CT.gov ID

NCT00208637

Collaborator

(none)

Enrollment

Location

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance	Behavioral: moderate carbohydrate, high protein diet (MCHP) Behavioral: high carbohydrate-high fibre (HCHF) diet	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Aug 1, 2002

Study Completion Date :

Dec 1, 2004

Outcome Measures

Primary Outcome Measures

Dietary intake as measured by 3-day weight diet records []

Secondary Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edgar National Centre for Diabetes Research	Dunedin	Otago	New Zealand	9001

Sponsors and Collaborators

Edgar National Centre for Diabetes Research

Investigators

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