Low Glycemic Index Diets vs. High Cereal Fibre Diets in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effect of Low Glycemic Index Diets on Glucose Control in Non-Insulin Dependent Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438698
• Other study ID #: REB 04-021
• Secondary ID: CIHR RCT#: 67894
• Status: Completed
• Phase: N/A
• First received: February 21, 2007
• Last updated: December 15, 2015
• Start date: September 2004
• Est. completion date: June 2007

Study information

• Verified date: December 2015
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

Large observational studies have shown cereal fiber to protect from diabetes and heart disease. Despite the success of acarbose, an α-glucosidase hydrolase inhibitor, which lowers the glycemic index of foods containing starch, sucrose and maltodextrins, the use of diets containing low glycemic index foods still remains to be established. We will therefore provide otherwise healthy individuals with type 2 diabetes intensive counseling on food selection either to improve glucose control using high cereal fiber dietary strategies or low glycemic index foods. Studies will last 6 months with bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for either or both diets then use of high fiber and/or low glycemic index foods in the diet may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.

Description:

Recruitment: Subjects will be recruited by placing advertisements in local newspapers and by distributing similar advertisements to the diabetes clinic and diabetes education programs.

Information Sessions: Approximately 1000 volunteers in groups of 10-30 with or without spouses will attend one of a number of evening information sessions run from the Risk Factor Modification Center at St. Michael's Hospital. During the sessions the exact nature of the study will be described and volunteers will have the opportunity to ask specific questions about the study and taste the high fiber and low glycemic index foods.

Screening: Potential subjects will then fill in and return to the investigators a detailed questionnaire concerning their medical history, medications (including vitamin, mineral and nutritional supplements) smoking habits, alcohol intake and exercise pattern and whether they are currently on a specific diet. Details will also be obtained concerning planned vacations. Those subjects deemed potentially eligible will be asked to give a fasting blood sample at the Risk Factor Modification Center. Individuals who meet the study criteria, are invited to return again to the Center. The principles of the diabetic diet which they are already expected to be following will be reinforced, which incorporate the key elements of an NCEP Step 2 diet (total calories from fat <30%, saturated fat <7%, polyunsaturated fat <10%, dietary cholesterol <200 mg/day).

All subjects will then be randomized to one 24-week treatment in a two-treatment parallel design.

Treatments: 1) low glycemic index dietary advice (e.g. to eat intact grain cereals, pumpernickel bread, parboiled rice, cracked wheat, pasta, peas, beans and lentils) 2) high cereal fiber diet. Background diets will be the subjects' diabetic diets, modified as above, which will conform to CDA and NCEP Step 2 guidelines. Diet histories will be recorded at weeks 0, 2, 4, 8, 12, 16 and 24. These diets will be assessed for consistency by the dietitian in the subject's presence. Where necessary, modifications in diet will be made to ensure weight maintenance. Compliance will be assessed by 7 day food records.

Duration: the study will consist of four months recruitment and patient selection, during which time estimation of individual caloric requirements will be performed, and 6 months treatment period

Study Details: Fasting blood samples are obtained at day zero and weeks 2, 4, 8, 12, 16 and 24 of each study period. Twenty-four hour urine for urinary C-peptide analyses will be obtained immediately prior to the beginning of the study and at the end of each 24-week treatment phase.

Palatability and satiety: subjects will record their ratings using a 9-point bipolar semantic scale at weekly intervals during each study phase.

Anthropometric measures: height at recruitment, waist and hip circumference, and body composition will be taken immediately prior to and at the end of each study phase. Body weight and blood pressure will be measured at clinic visits.

This study will help to indicate whether dietary advice can make a significant difference to glycemic control as has been the case with drug therapy to reduce postprandial glycemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 100 Years

Eligibility

Inclusion Criteria:

• Men and postmenopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (Sulfonylureas, Biguanides, Thiazolidinediones , and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study

• HbA1c between 6.5 and 8.0% at recruitment

• living within a 40 km radius of St. Michael's Hospital

• Diabetes diagnosed > 6 months prior to randomization

Exclusion Criteria:

• diabetic complications: clinically significant gastroparesis, retinopathy, nephropathy, neuropathy, hepatic disease, or CHD (current clinically significant CHD e.g. unstable angina)

• taking insulin or acarbose

• smoking or significant alcohol intake (> 1 drink/day)

• serum triglycerides > 4.0 mmol/L

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Low Glycemic Index diet
Diet to emphasize carbohydrate foods low in glycemic index
• High Cereal Fibre Diets
Diet to emphasize whole wheat carbohydrate cgoices

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c		6 months	Yes
Primary	Change in Fasting Glucose		6 months	Yes
Secondary	serum FFA		6 months	No
Secondary	C-peptide		6 months	No
Secondary	CRP		6 months	No
Secondary	IGF-I		6 months	No
Secondary	IGFBP-3		6 months	No
Secondary	Serum apo AI		6 months	No
Secondary	apo B		6 months	No
Secondary	apo Lp(a)		6 months	No
Secondary	amino acids		6 months	No
Secondary	Plasma lipids and lipoproteins (TG, LDL, HDL)		6 months	No
Secondary	Oxidized LDL		6 months	No
Secondary	Change in Urinary creatinine		6 months	No
Secondary	urea		6 months	No
Secondary	Urinary C-peptide		6 months	No