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

NCT01063361 | Completed Phase 2 DMC

• 1 other identifier: 09-192
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• change in HbA1c

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

• serum lipids

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

Secondary Outcomes (4)

• fasting glucose

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

• change in weight, waist and hip circumference

  weeks 0, 12

• blood pressure

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

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

  0, 12 weeks.

Study Arms (2)

Low glycemic Index Diet

EXPERIMENTAL

Low glycemic Index Diet, emphasizing pulses

Dietary Supplement: Low glycemic index diet with pulses

High Cereal Fibre Diet

ACTIVE COMPARATOR

Dietary Supplement: High Cereal Fibre

Interventions

Low glycemic index diet with pulses DIETARY_SUPPLEMENT

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

Low glycemic Index Diet

High Cereal Fibre DIETARY_SUPPLEMENT

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

High Cereal Fibre Diet

Eligibility Criteria

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

You may qualify if:

• 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

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
• Saskatchewan Pulse Growers: collaborator
• Pulse Canada: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

• 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. doi: 10.1001/2013.jamainternmed.70.

  PMID: 23089999 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pulse

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

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: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

CA (1)