Clinical trial NCT01063361: Low Glycemic Index Diets (With Pulses) in Type 2 Diabetes
Official title: Effect of Low Glycemic Index Diets (With Pulses) on Glucose Control in Non-Insulin Dependent Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Saskatchewan Pulse Growers
name: Pulse Canada
First posted: 2010-02-05
Enrollment: 131
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 8.5% 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

Primary outcomes:
measure: change in HbA1c
timeFrame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
measure: serum lipids
timeFrame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
Secondary outcomes:
measure: fasting glucose
timeFrame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
measure: change in weight, waist and hip circumference
timeFrame: weeks 0, 12
measure: blood pressure
timeFrame: from prestudy and week 0, to end of treatment weeks 8, 10, and 12
measure: creatine, urea, and c-peptides in 24 hour urine collection
timeFrame: 0, 12 weeks.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References:
citation: 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.