Low Glycemic Index Diet for Type 2 Diabetics

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
David Jenkins, University of Toronto
ClinicalTrials.gov Identifier:
NCT01063374
First received: February 3, 2010
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

A low glycemic index diet may improve glycemic control and reduce plaque buildup in arteries of those with type 2 diabetes. Subjects will be randomly assigned to receive dietary advice on either a low glycemic index diet, or a high cereal fibre diet, for three years.


Condition Intervention Phase
Type 2 Diabetes
Dietary Supplement: low glycemic diet instruction
Dietary Supplement: high cereal fibre diet instruction
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Glycemic Index Diets to Improve Glycemic Control and Cardiovascular Disease in Type 2 Diabetics

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • plaque volume [ Time Frame: 1, 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • intima media thickness [ Time Frame: 0, 1, and 3 years ] [ Designated as safety issue: Yes ]
  • plaque morphology [ Time Frame: 0, 1, 3 years ] [ Designated as safety issue: Yes ]
  • HbA1c [ Time Frame: every 3 months for 3 years ] [ Designated as safety issue: Yes ]
  • serum lipids [ Time Frame: every 3 months for 3 years ] [ Designated as safety issue: Yes ]
  • blood pressure [ Time Frame: every 3 months for 3 years ] [ Designated as safety issue: Yes ]
  • serum fasting glucose [ Time Frame: creatinine, urea, and C-peptides in 24 hour urine collection ] [ Designated as safety issue: Yes ]
  • anthropometric measures (weight, waist and hip circumference) [ Time Frame: every 3 months for 3 years ] [ Designated as safety issue: Yes ]
  • retinal photography [ Time Frame: 1, 3 years ] [ Designated as safety issue: Yes ]
    ophthalmological assessment using fundoscopy


Estimated Enrollment: 160
Study Start Date: March 2010
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: low glycemic index, diabetic diet
low glycemic index, diabetic diet
Dietary Supplement: low glycemic diet instruction
Active Comparator: high cereal fibre, diabetic diet
high cereal fibre, diabetic diet
Dietary Supplement: high cereal fibre diet instruction

Detailed Description:

All subjects will be randomized to one 3-year treatment in a two-treatment parallel design.

Treatments:

  1. low glycemic index dietary advice (e.g. to eat intact grain cereals, parboiled rice, cracked wheat, pasta, peas, beans, lentils, and baked goods made from legume flour); or
  2. a high cereal fiber diet emphasizing whole grains. Duration: The study will consist of approximately two months of recruitment and patient selection, during which time estimation of individual caloric requirements will be assessed, and a 3 year treatment period assigned.

Study Details: Fasting blood samples are obtained at screening, week -2, and months 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 each study period. HbA1c will be assessed on all visits. A carotid ultrasound (CUS) (screening, months 0, 12 and 36) and magnetic resonance imaging (MRI) (months 0, 12 and 36) technologies will be used to assess arterial wall thickening and changes in the nature of carotid plaques. Twenty-four hour urine for urinary C-peptide analyses will be obtained immediately prior to the beginning of the study and at the end of each 3 year treatment phase. At the end of the 3 year treatment period, subjects who wish to undertake the alternate treatment will be given appropriate instruction.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 8.0% at screening and at the prestudy visit
  • 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
  • If HbA1c rises above 8.5% over two consecutive routine measurements, subjects will be referred back to their family doctors for an increase in anti hyperglycemic medications according to a predetermined protocol.
  • Any condition or circumstance which would prevent an individual from having an MRI (e.g. individuals with prostheses or metal implants, or those who are excessively claustrophobic)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063374

Locations
Canada, Ontario
Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
Toronto, Ontario, Canada, M5C 2T2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
University of Toronto
Canadian Institutes of Health Research (CIHR)
  More Information

No publications provided

Responsible Party: David Jenkins, Principle Investigator, University of Toronto
ClinicalTrials.gov Identifier: NCT01063374     History of Changes
Other Study ID Numbers: 09-193
Study First Received: February 3, 2010
Last Updated: June 18, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014