ClinicalTrials.Veeva

Menu

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

U

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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

131 participants in 2 patient groups

Low glycemic Index Diet
Experimental group
Description:
Low glycemic Index Diet, emphasizing pulses
Treatment:
Dietary Supplement: Low glycemic index diet with pulses
High Cereal Fibre Diet
Active Comparator group
Treatment:
Dietary Supplement: High Cereal Fibre

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems