Status:
COMPLETED
Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Canadian Diabetes Association
Conditions:
Diabetes Mellitus
Overweight
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
Brief Summary
Canadian statistics indicate that the incidence of obesity is increasing and that the occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy weight, making weight cont...
Eligibility Criteria
Inclusion
- Well-controlled type 2 diabetes for at least 1 year
- Treated with diet and/or oral hypoglycemic medications
- BMI 25-40 kg/m2
Exclusion
- Weight change in the past three months \>10% of body weight
- On insulin therapy
- Unstable angina, myocardial infarction or stroke (within 6 months)
- Planned surgery or pregnancy
- Blood pressure \>160mmHg/100mmHg
- Surgical procedures for weight loss and concomitant use of medication or supplements that alter body weight or appetite
- ALA, dietary fibre, fish oil supplements or consuming cold-water fish more than three times per week
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01403571
Start Date
October 1 2009
End Date
August 1 2015
Last Update
October 5 2016
Active Locations (1)
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1
Risk Factor Modification Centre, St. Michael's
Toronto, Ontario, Canada, M5B1W8