Low Glycemic Index Diet for Type 2 Diabetics

NCT01063374 | Completed Phase 2 DMC

• 1 other identifier: 09-193
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• plaque volume

  1, 3 years

Secondary Outcomes (8)

• intima media thickness

  0, 1, and 3 years

• plaque morphology

  0, 1, 3 years

• HbA1c

  every 3 months for 3 years

• serum lipids

  every 3 months for 3 years

• blood pressure

  every 3 months for 3 years

Study Arms (2)

low glycemic index, diabetic diet

ACTIVE COMPARATOR

low glycemic index, diabetic diet

Dietary Supplement: low glycemic diet instruction

high cereal fibre, diabetic diet

ACTIVE COMPARATOR

high cereal fibre, diabetic diet

Dietary Supplement: high cereal fibre diet instruction

Interventions

low glycemic diet instruction DIETARY_SUPPLEMENT

low glycemic index, diabetic diet

high cereal fibre diet instruction DIETARY_SUPPLEMENT

high cereal fibre, diabetic diet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (2)

• Chiavaroli L, Mirrahimi A, Ireland C, Mitchell S, Sahye-Pudaruth S, Coveney J, Olowoyeye O, Patel D, de Souza RJ, Augustin LS, Bashyam B, Pichika SC, Blanco Mejia S, Nishi SK, Leiter LA, Josse RG, McKeown-Eyssen GE, Moody AR, Kendall CW, Sievenpiper JL, Jenkins DJ. Cross-sectional associations between dietary intake and carotid intima media thickness in type 2 diabetes: baseline data from a randomised trial. BMJ Open. 2017 Mar 22;7(3):e015026. doi: 10.1136/bmjopen-2016-015026.

  PMID: 28336747 DERIVED

• Chiavaroli L, Mirrahimi A, Ireland C, Mitchell S, Sahye-Pudaruth S, Coveney J, Olowoyeye O, Maraj T, Patel D, de Souza RJ, Augustin LS, Bashyam B, Blanco Mejia S, Nishi SK, Leiter LA, Josse RG, McKeown-Eyssen G, Moody AR, Berger AR, Kendall CW, Sievenpiper JL, Jenkins DJ. Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial. BMJ Open. 2016 Jul 7;6(7):e012220. doi: 10.1136/bmjopen-2016-012220.

  PMID: 27388364 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David Mazer

  St. Michael's Hospital Research Ethics Board

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 5, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)