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

Insulin Resistance Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208637
• Other study ID #: Kai Study
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: August 2002
• Est. completion date: December 2004

Study information

• Verified date: September 2005
• Source: Edgar National Centre for Diabetes Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Behavioral:
• moderate carbohydrate, high protein diet (MCHP)

• high carbohydrate-high fibre (HCHF) diet

Locations

Country	Name	City	State
New Zealand	Edgar National Centre for Diabetes Research	Dunedin	Otago

Sponsors (1)

Lead Sponsor	Collaborator
Edgar National Centre for Diabetes Research

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary intake as measured by 3-day weight diet records
Secondary	Blood pressure
Secondary	Bioelectric Impedence
Secondary	Weight
Secondary	Waist circumference
Secondary	Total cholesterol and lipid subfractions (LDL, HDL)
Secondary	Fasting insulin
Secondary	Lipoprotein A + B
Secondary	Inflammatory markers
Secondary	Urinary albumin:creatinine ratio
Secondary	Quality of life
Secondary	All measures to be compared at end of study (6 months)

External Links

•   Edgar National Centre for Diabetes Research, NZ website