Low Glycemic Index Diets (With Pulses) in Type 2 Diabetes

University of Toronto

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes

Treatments

Dietary Supplement: Low glycemic index diet with pulses

Dietary Supplement: High Cereal Fibre

Study type

Interventional

Funder types

Other

Identifiers

NCT01063361

09-192

Details and patient eligibility

About

Healthy individuals with type 2 diabetes will receive intensive counseling on food selection to improve glucose control using either high cereal fiber dietary strategies or low glycemic index foods emphasizing dried legumes and their products. The treatments will last 3 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.

Enrollment

131 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Men and women with type 2 diabetes who

are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks
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: Individuals who

take insulin
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