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Completed

NCT Number: NCT01063361

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low glycemic index diet with pulses

Dietary Supplement

Subjects will be advised to follow a diabetic diet, using low glycemic index foods, emphasizing pulses.

High Cereal Fibre

Dietary Supplement

Subjects will be advised to follow a healthy high fibre diabetic diet.

Primary outcomes

  1. change in HbA1c

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

  2. serum lipids

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

Secondary outcomes

  1. fasting glucose

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

  2. change in weight, waist and hip circumference

    Time frame: weeks 0, 12

  3. blood pressure

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

  4. creatine, urea, and c-peptides in 24 hour urine collection

    Time frame: 0, 12 weeks.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Pulse Canada
  • Saskatchewan Pulse Growers

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2015
First posted
Feb 5, 2010
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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