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

Type 2 Diabetes Clinical Trial

Official title:

Effect of Low Glycemic Index Diets (With Pulses) on Glucose Control in Non-Insulin Dependent Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063361
• Other study ID #: 09-192
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2010
• Last updated: December 7, 2015
• Start date: February 2010
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: August 2015
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Low glycemic index diet with pulses
Subjects will be advised to follow a diabetic diet, using low glycemic index foods, emphasizing pulses.
• High Cereal Fibre
Subjects will be advised to follow a healthy high fibre diabetic diet.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Pulse Canada, Saskatchewan Pulse Growers

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in HbA1c		from prestudy and week 0, to end of treatment weeks 8, 10, and 12	Yes
Primary	serum lipids		from prestudy and week 0, to end of treatment weeks 8, 10, and 12	Yes
Secondary	fasting glucose		from prestudy and week 0, to end of treatment weeks 8, 10, and 12	Yes
Secondary	change in weight, waist and hip circumference		weeks 0, 12	Yes
Secondary	blood pressure		from prestudy and week 0, to end of treatment weeks 8, 10, and 12	Yes
Secondary	creatine, urea, and c-peptides in 24 hour urine collection		0, 12 weeks.	Yes