Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/07/2004
Date assigned
22/07/2004
Last edited
18/04/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cyril W C Kendall

ORCID ID

Contact details

University of Toronto
Department of Nutritional Sciences
Faculty of Medicine
150 College Street
Room 340
Toronto
ON
M5S 3E2
Canada
cyril.kendall@utoronto.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT 67894

Study information

Scientific title

Acronym

Study hypothesis

Low glycemic index diets will improve glycemic control in type two diabetic subjects treated with oral agents.

Ethics approval

Approval received from:
1. St. Michael's Hospital REB (ref: 04-021c)
2. University of Toronto REB (ref: 17914)

As of 20/08/2007: The sample size was approved to be increased to 200 subjects by St. Michael's Hospital Ethics Board on 31 October 2006 (REB#04-021).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Type two Diabetes

Intervention

Control:
Advice to consume a high cereal fibre, whole grain, normal Glycemic Index (GI) diet (mean GI = 80).

Test:
Advice to consume a low glycemic index diet (mean GI less than 70) based on differences in the particle size and nature of the study foods but with similar fibre content to the 'control diet'.

For further information, please contact the principal investigator Dr David Jenkins or the principal co-investigator Dr Cyril Kendall at the address listed below.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Treatment difference in the change in HbA1c accross treatments.

Secondary outcome measures

1. Fasting blood glucose
2. Fasting insulin
3. High sensitivity C-Reactive Protein (hs-CRP)
4. Oxidized Low Density Lipoprotein (LDL)
5. LDL particle size
6. High Density Lipoprotein (HDL)
7. Change in body weight or oral hypoglycemic agents

Overall trial start date

01/09/2004

Overall trial end date

01/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and postmenopausal women with type two diabetes, greater than or equal to 18 years old
2. On oral hypoglycemic agents
3. Have fasting plasma HbA1c concentrations between 6.5 and 8.0%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Target number amended as of 20/08/2007: 200. Target number at time of registration: 144.

Participant exclusion criteria

1. Diabetic complications: clinically significant gastroparesis, retinopathy, nephropathy, neuropathy, hepatic disease or Coronary Heart Disease (CHD) (major coronary event)
2. Major surgery less than six months prior to randomisation, treatment with insulin, acarbose, steroids, or having serum triglycerides more than or equal to 4.0 mmol/L

Recruitment start date

01/09/2004

Recruitment end date

01/06/2007

Locations

Countries of recruitment

Canada

Trial participating centre

University of Toronto
Toronto, ON
M5S 3E2
Canada

Sponsor information

Organisation

Canadian Institutes of Health Research (CIHR) (Canada)

Sponsor details

Room 97
160 Elgin Street
Address locator: 4809A
Ottawa
ON
K1A OW9
Canada
+1 888 603 4178
info@cihr-irsc.gc.ca

Sponsor type

Research organisation

Website

http://www.cihr-irsc.gc.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT 67894)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes