Status:
UNKNOWN
Effect of Nuts vs. a Wheat Bran Muffin in Type 2 Diabetes
Lead Sponsor:
University of Toronto
Conditions:
Type 2 Diabetes
Cardiovascular Disease
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
To determine if tree nuts (Almonds, Hazelnuts, Pistachios, Peanuts, Macadamia nuts, Pecans, Walnuts and Cashews) improve glycemic control in type 2 diabetes, as assessed by HbA1c and serum fructosamin...
Detailed Description
The investigators wish to study the effect of nuts on glycemic control and to confirm their lipid lowering effects in type 2 diabetes. The consumption of nuts with their high unsaturated fat, vegetabl...
Eligibility Criteria
Inclusion
- Men and post menopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (sulfonylureas (glyburide), biguanides (metformin), Thiazolidinediones (TZDs) and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study;
- HbA1c of 6.5 to 8.0% as a compromise between those whose levels are acceptable and the level which is currently considered unacceptable.
- Diabetes diagnosed \>6 months prior to randomization
- Weight stable within 3% body weight \>2 months.
Exclusion
- Use of acarbose
- Use of Insulin
- Known nut allergies
- Clinically significant gastroparesis
- Use of steroids
- Presence of GI disease (celiac disease, ulcerative colitis, and Crohns)
- Major cardiovascular event (stroke or myocardial infarction)
- Major surgery \< 6 months prior to randomization
- Presence of major debilitating disorder such as clinically significant liver disease (not including non-alcoholic fatty liver (NAFL) or non-alcoholic steatohepatitis (NASH) but including cirrhosis, infectious hepatitis (B and C), aspartate transaminase (AST) or alanine transaminase (ALT) \> 130 IU/L)
- Renal failure (high creatinine \> 150 mmol/L)
- Serum triglyceride \> 6 mmol/L.
- Patients currently undergoing treatment for cancer with the exception of non-melanoma skin cancer, but not high risk patients or those whose treatment has been successfully completed.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00410722
Start Date
December 1 2006
Last Update
January 9 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2