Low Glycemic Index Diets vs. High Cereal Fibre Diets in Type 2 Diabetes
Effect of Low Glycemic Index Diets on Glucose Control in Non-Insulin Dependent Diabetics
2 other identifiers
interventional
210
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Sep 2004
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 21, 2007
CompletedFirst Posted
Study publicly available on registry
February 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedDecember 16, 2015
December 1, 2015
2.7 years
February 21, 2007
December 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Hemoglobin A1c
6 months
Change in Fasting Glucose
6 months
Secondary Outcomes (14)
serum FFA
6 months
C-peptide
6 months
CRP
6 months
IGF-I
6 months
IGFBP-3
6 months
- +9 more secondary outcomes
Study Arms (2)
Low Glycemic Index Diet
EXPERIMENTALDiet with low glycemic index carbohydrates
High Fiber Diet
ACTIVE COMPARATORDiet with high cereal fibre choices
Interventions
Diet to emphasize carbohydrate foods low in glycemic index
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Michael's Hospital
Toronto, Ontario, M5C 2T2, Canada
Related Publications (4)
Kavanagh ME, Back S, Chen V, Glenn AJ, Viscardi G, Houshialsadat Z, Sievenpiper JL, Kendall CWC, Jenkins DJA, Chiavaroli L. The Portfolio Diet and HbA1c in Adults Living with Type 2 Diabetes Mellitus: A Patient-Level Pooled Analysis of Two Randomized Dietary Trials. Nutrients. 2024 Aug 23;16(17):2817. doi: 10.3390/nu16172817.
PMID: 39275135DERIVEDHa V, Viguiliouk E, Kendall CWC, Balachandran B, Jenkins DJA, Kavsak PA, Sievenpiper JL. Effect of a low glycemic index diet versus a high-cereal fibre diet on markers of subclinical cardiac injury in healthy individuals with type 2 diabetes mellitus: An exploratory analysis of a randomized dietary trial. Clin Biochem. 2017 Dec;50(18):1104-1109. doi: 10.1016/j.clinbiochem.2017.09.021. Epub 2017 Sep 25.
PMID: 28958804DERIVEDJenkins DJ, Srichaikul K, Kendall CW, Sievenpiper JL, Abdulnour S, Mirrahimi A, Meneses C, Nishi S, He X, Lee S, So YT, Esfahani A, Mitchell S, Parker TL, Vidgen E, Josse RG, Leiter LA. The relation of low glycaemic index fruit consumption to glycaemic control and risk factors for coronary heart disease in type 2 diabetes. Diabetologia. 2011 Feb;54(2):271-9. doi: 10.1007/s00125-010-1927-1. Epub 2010 Oct 27.
PMID: 20978741DERIVEDJenkins DJ, Kendall CW, McKeown-Eyssen G, Josse RG, Silverberg J, Booth GL, Vidgen E, Josse AR, Nguyen TH, Corrigan S, Banach MS, Ares S, Mitchell S, Emam A, Augustin LS, Parker TL, Leiter LA. Effect of a low-glycemic index or a high-cereal fiber diet on type 2 diabetes: a randomized trial. JAMA. 2008 Dec 17;300(23):2742-53. doi: 10.1001/jama.2008.808.
PMID: 19088352DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David JA Jenkins, MD, PhD
University of Toronto, St. Michael's Hospital
- STUDY DIRECTOR
Cyril WC Kendall, PhD
University of Toronto, St. Michael's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 21, 2007
First Posted
February 22, 2007
Study Start
September 1, 2004
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
December 16, 2015
Record last verified: 2015-12