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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Saskatchewan Pulse Growers
Pulse Canada
Information provided by (Responsible Party):
David Jenkins, University of Toronto
ClinicalTrials.gov Identifier:
NCT01063361
First received: February 3, 2010
Last updated: June 18, 2013
Last verified: June 2013

February 3, 2010
June 18, 2013
February 2010
August 2011   (final data collection date for primary outcome measure)
  • change in HbA1c [ Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12 ] [ Designated as safety issue: Yes ]
  • serum lipids [ Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12 ] [ Designated as safety issue: Yes ]
  • HbA1c [ Time Frame: screening, weeks 0, 4, 8, 10, and 12 ] [ Designated as safety issue: Yes ]
  • serum lipids [ Time Frame: screening, weeks 0, 2, 4, 8, 10, and 12 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01063361 on ClinicalTrials.gov Archive Site
  • fasting glucose [ Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12 ] [ Designated as safety issue: Yes ]
  • change in weight, waist and hip circumference [ Time Frame: weeks 0, 12 ] [ Designated as safety issue: Yes ]
  • blood pressure [ Time Frame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12 ] [ Designated as safety issue: Yes ]
  • creatine, urea, and c-peptides in 24 hour urine collection [ Time Frame: 0, 12 weeks. ] [ Designated as safety issue: Yes ]
  • fasting glucose [ Time Frame: screening, weeks 0, 2, 4, 8, 10, and 12 ] [ Designated as safety issue: Yes ]
  • weight, waist and hip circumference [ Time Frame: screening, weeks 0, 2, 4, 8, 10, and 12 ] [ Designated as safety issue: Yes ]
  • blood pressure [ Time Frame: screening, weeks 0, 2, 4, 8, 10, and 12 ] [ Designated as safety issue: Yes ]
  • creatine, urea, and c-peptides in 24 hour urine collection [ Time Frame: 0, 12 weeks. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Low Glycemic Index Diets (With Pulses) in Type 2 Diabetes
Effect of Low Glycemic Index Diets (With Pulses) on Glucose Control in Non-Insulin Dependent Diabetics

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Dietary Supplement: Low glycemic index diet with pulses
    Subjects will be advised to follow a diabetic diet, using low glycemic index foods, emphasizing pulses.
  • Dietary Supplement: High Cereal Fibre
    Subjects will be advised to follow a healthy high fibre diabetic diet.
  • Experimental: Low glycemic Index Diet
    Low glycemic Index Diet, emphasizing pulses
    Intervention: Dietary Supplement: Low glycemic index diet with pulses
  • Active Comparator: High Cereal Fibre Diet
    Intervention: Dietary Supplement: High Cereal Fibre
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
131
August 2015
August 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01063361
09-192
Yes
David Jenkins, University of Toronto
University of Toronto
  • Saskatchewan Pulse Growers
  • Pulse Canada
Not Provided
University of Toronto
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP