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Clinical Trials/NCT01063361
NCT01063361CompletedPhase 2

Effect of Low Glycemic Index Diets (With Pulses) on Glucose Control in Non-Insulin Dependent Diabetics

University of Toronto2 sites in 1 country131 target enrollmentStarted: February 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
131
Locations
2
Primary Endpoint
change in HbA1c
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

change in HbA1c

Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12

serum lipids

Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12

Secondary Outcomes

  • creatine, urea, and c-peptides in 24 hour urine collection(0, 12 weeks.)
  • change in weight, waist and hip circumference(weeks 0, 12)
  • fasting glucose(from prestudy and week 0, to end of treatment weeks 8, 10, and 12)
  • blood pressure(from prestudy and week 0, to end of treatment weeks 8, 10, and 12)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Jenkins

Principle Investigator

University of Toronto

Study Sites (2)

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