Low Glycemic Index Diets (With Pulses) in Type 2 Diabetes
NCT ID: NCT01063361
Last Updated: 2015-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
131 participants
INTERVENTIONAL
2010-02-28
2015-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low glycemic Index Diet
Low glycemic Index Diet, emphasizing pulses
Low glycemic index diet with pulses
Subjects will be advised to follow a diabetic diet, using low glycemic index foods, emphasizing pulses.
High Cereal Fibre Diet
High Cereal Fibre
Subjects will be advised to follow a healthy high fibre diabetic diet.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low glycemic index diet with pulses
Subjects will be advised to follow a diabetic diet, using low glycemic index foods, emphasizing pulses.
High Cereal Fibre
Subjects will be advised to follow a healthy high fibre diabetic diet.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* have a HbA1c in the range of 6.5% to 8.5% at screening and at the visit prior to randomization
* have diabetes diagnosed \>6 months
* have maintained stable weight for 2 months (within 3%)
* have a valid OHIP card and a family physician
* if prescribed lipid medication, have taken a stable dose for at least 2 weeks
* if prescribed blood pressure medication, have taken a stable dose for at least 1 week
* can keep written food records, with the use of a digital scale
Exclusion Criteria
* take steroids
* have GI disease (gastroparesis, celiac disease, ulcerative colitis, Crohn's Disease, IBS)
* have had a major cardiovascular event (stroke or myocardial infarction) in the past 6 months
* take warfarin (Coumadin)
* have had major surgery in the past 6 months
* have a major debilitating disorder
* have clinically significant liver disease (AST or ALT \> 130 U/L), excluding NAFL or NASH
* have hepatitis B or C
* have renal failure (high creatinine \> 150 mmol/L)
* have serum triglycerides ≥ 6.0 mmol/L
* have a history of cancer, except non-melanoma skin cancer (basal cell, squamous cell)
* have food allergies to study food components
* have elevated blood pressure (\> 145/90) unless approved by GP
* have acute or chronic infections (bacterial or viral)
* have chronic inflammatory diseases (e.g. rheumatoid arthritis, lupus; ulcerative colitis)
* have other conditions which in the opinion of any of the investigators would make them unsuitable for the study
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Saskatchewan Pulse Growers
OTHER
Pulse Canada
OTHER
University of Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David Jenkins
Principle Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Michael's Hospital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jenkins DJ, Kendall CW, Augustin LS, Mitchell S, Sahye-Pudaruth S, Blanco Mejia S, Chiavaroli L, Mirrahimi A, Ireland C, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Leiter LA, Josse RG. Effect of legumes as part of a low glycemic index diet on glycemic control and cardiovascular risk factors in type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2012 Nov 26;172(21):1653-60. doi: 10.1001/2013.jamainternmed.70.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09-192
Identifier Type: -
Identifier Source: org_study_id