Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00208637




Registration number
NCT00208637
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
21/09/2005

Titles & IDs
Public title
He Purongo Mo Nga Kai Hei Arai i Te Matehuka - Dietary Diabetes Prevention Study for Maori
Scientific title
Secondary ID [1] 0 0
Kai Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin Resistance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - moderate carbohydrate, high protein diet (MCHP)
Behaviour - high carbohydrate-high fibre (HCHF) diet

Behaviour: moderate carbohydrate, high protein diet (MCHP)


Behaviour: high carbohydrate-high fibre (HCHF) diet
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dietary intake as measured by 3-day weight diet records
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Blood pressure
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Bioelectric Impedence
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Weight
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Waist circumference
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Total cholesterol and lipid subfractions (LDL, HDL)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Fasting insulin
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Lipoprotein A + B
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Inflammatory markers
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Urinary albumin:creatinine ratio
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Quality of life
Timepoint [10] 0 0
Secondary outcome [11] 0 0
All measures to be compared at end of study (6 months)
Timepoint [11] 0 0

Eligibility
Key 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
Minimum age
17 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Otago

Funding & Sponsors
Primary sponsor type
Other
Name
Edgar National Centre for Diabetes Research
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00208637
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lorraine Brooking, BSc, MA
Address 0 0
Edgar National Centre for Diabetes Research, Dunedin, NZ
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT00208637