Clinical trial NCT00208637: He Purongo Mo Nga Kai Hei Arai i Te Matehuka - Dietary Diabetes Prevention Study for Maori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Maori
insulin sensitivity
cardiovascular risk
diabetes prevention
diet modification
Lead sponsor: Edgar National Centre for Diabetes Research
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dietary intake as measured by 3-day weight diet records
Secondary outcomes:
measure: Blood pressure
measure: Bioelectric Impedence
measure: Weight
measure: Waist circumference
measure: Total cholesterol and lipid subfractions (LDL, HDL)
measure: Fasting insulin
measure: Lipoprotein A + B
measure: Inflammatory markers
measure: Urinary albumin:creatinine ratio
measure: Quality of life
measure: All measures to be compared at end of study (6 months)
Other outcomes:
Locations:
city: Dunedin
country: New Zealand
facility: Edgar National Centre for Diabetes Research
state: Otago
Study officials:
affiliation: Edgar National Centre for Diabetes Research, Dunedin, NZ
name: Lorraine Brooking, BSc, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Edgar National Centre for Diabetes Research, Dunedin, NZ
name: Jim I Mann, FRACP, PhD
role: STUDY_DIRECTOR
References:
citation: 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.