Status:
COMPLETED
Diabetes Aerobic and Resistance Exercise (DARE) Study
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
University of Ottawa
Conditions:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
The main purpose of this study is to assess the impact of exercise training (aerobic exercise, resistance exercise, combined aerobic and resistance exercise) versus a sedentary waiting list control on...
Detailed Description
Background. The incidence of type 2 diabetes mellitus in the Western world is rising rapidly due to increases in obesity and sedentary behaviour, and diabetes is among the most potent common risk fact...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus as defined by the 1998 CDA Guidelines
- Male or female
- treated with diet and/or oral agents (no insulin)
- age 40-70
- HbA1c 0.066-0.099
Exclusion
- Participation during the previous 6 months in a regular program of exercise or aerobic sports greater than 2 times per week for at least 20 minutes per session, or in any resistance training during the previous 6 months
- Insulin therapy, or uncontrolled hyperglycemia (HbA1c\>0.099). Insulin therapy is an exclusion criterion because it would render HOMA insulin sensitivity calculation invalid.
- Changes in medications for diabetes, BP or lipids in the 2 months prior to enrollment.
- Significant weight change (increase or decrease of greater than 5% of body weight during the two months before enrollment).
- Significant renal disease: serum creatinine greater than 200 mEq/l. or proteinuria \>1 g/24 hours.
- Uncontrolled hypertension: BP \>160 mm Hg systolic or \>95 mm Hg diastolic BP in a sitting position.
- Restrictions in physical activity due to disease: intermittent claudication, severe peripheral neuropathy or active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis.
- Other illness, judged by the patient or study physician to make participation in this study inadvisable.
- Significant cognitive deficit resulting in inability to understand or comply with instructions.
- Pregnancy at the start of the study, or intention to become pregnant in the next year.
- Inability to communicate in English or French.
- Unwillingness to sign informed consent.
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT00195884
Start Date
September 1 1999
End Date
April 1 2011
Last Update
January 23 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 7W9