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

This study has been completed.
Sponsor:
Information provided by:
Edgar National Centre for Diabetes Research
ClinicalTrials.gov Identifier:
NCT00208637
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention
Insulin Resistance
Behavioral: moderate carbohydrate, high protein diet (MCHP)
Behavioral: high carbohydrate-high fibre (HCHF) diet

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

Resource links provided by NLM:


Further study details as provided by Edgar National Centre for Diabetes Research:

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)

Estimated Enrollment: 90
Study Start Date: August 2002
Estimated Study Completion Date: December 2004
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

Ages Eligible for Study:   17 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208637

Locations
New Zealand
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
  More Information

Additional Information:
No publications provided by Edgar National Centre for Diabetes Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00208637     History of Changes
Other Study ID Numbers: Kai Study
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by Edgar National Centre for Diabetes Research:
Maori
insulin sensitivity
cardiovascular risk
diabetes prevention
diet modification

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 30, 2014