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ISRCTN
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ISRCTN32261256
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ClinicalTrials.gov identifier
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NCT00195884
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Public title
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Diabetes Aerobic and Resistance Exercise (DARE) trial
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Scientific title
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Effects of aerobic exercise, resistance exercise, or both in type 2 diabetes: a randomised trial
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Acronym
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DARE
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Serial number at source
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MCT-44155
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Study hypothesis
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To assess the impact of exercise training (aerobic exercise, resistance exercise, combined aerobic and resistance exercise) versus a sedentary waiting list control on glycaemic control (as reflected in reduced haemoglobin A1c [HbA1c]), body composition (weight, body mass index [BMI], waist circumference, total body fat, visceral and subcutaneous abdominal fat, mid-thigh muscle cross-sectional area), lipids (Apo-B, Apo-A1, Apo-B/A1 ratio, low density lipoprotein (LDL) particle diameter, high-sensitivity C-reactive protein) and quality of life.
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Lay summary
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Ethics approval
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Loeb Health Research Institute at the Ottawa Hospital approved on the 25th March 1999
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Type 2 diabetes mellitus
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Participants - inclusion criteria
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1. Type 2 diabetes mellitus as defined by the 1998 CDA guidelines
2. Male or female, treated with diet and/or oral agents (no insulin), aged 40 - 70 years, HbA1c 0.066 - 0.099
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Participants - exclusion criteria
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1. Participation during the previous 6 months in a regular program of exercise or aerobic sports greater than or equal to 2 times/week for at least 20 minutes per session, or in any resistance training during the previous 6 months
2. Insulin therapy, or uncontrolled hyperglycaemia (HbA1c greater than 0.099). Insulin therapy is an exclusion criterion because it would render Homeostasis Model Assessment (HOMA) insulin sensitivity calculation invalid.
3. Changes in medications for diabetes in the 2 months prior to enrolment, or for blood pressure (BP) or lipids in the 1 month prior to enrolment
4. Significant weight change (increase or decrease of greater than or equal to 5% of body weight during the 2 months before enrolment)
5. Significant renal disease: serum creatinine greater than or equal to 200 mEq/1 or proteinuria greater than 1 g/24 hours
6. Uncontrolled hypertension: blood pressure (BP) greater than 160 mmHg systolic or greater than 95 mmHg diastolic BP in a sitting position
7. 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
8. Significant cognitive deficit resulting in inability to understand or comply with instructions
9. Other illness judged by the patient or study physician to make participation in this study inadvisable
10. Pregnancy at the start of the study, or intention to become pregnant in the next two years
11. Inability to communicate in English or French
12. Unwillingness to sign informed consent
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Anticipated start date
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01/04/2001
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Anticipated end date
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31/03/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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216
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Interventions
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Aerobic and resistance exercise training versus none.
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Primary outcome measure(s)
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Change in haemoglobin A1c (HbA1c) between baseline and end of the 6-month supervised exercise period. HbA1c is a reflection of the mean blood glucose over the previous 2 - 3 months.
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Secondary outcome measure(s)
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1.Change in health related quality of life
2. Nontraditional cardiovascular risk factors: Apo-B, Apo-A1, high-sensitivity C-reactive protein, LDL particle diameter, estimated insulin resistance
3. Blood pressure
4. Lipid concentrations
5. Body composition (weight, BMI, waist circumference, total body fat, visceral and subcutaneous abdominal fat, mid-thigh muscle cross-sectional area), lipids (Apo-B, Apo-A1, Apo-B/A1 ratio, LDL particle diameter, high-sensitivity C-reactive protein)
6. Resting metabolic rate
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Sources of funding
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1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44155) funding for all remaining subjects
2. Canadian Diabetes Association (Canada) - funding for first 28 subjects
3. University of Ottawa Interfaculty Grant (Canada) - funding for energy expenditure measurement on first 28 subjects
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17876019
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Contact name
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Dr
Ronald Jeremy
Sigal
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Address
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7th floor, North Tower
Foothills Medical Center
1403 29 Street NW
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City/town
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Calgary, Alberta
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Zip/Postcode
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T2N 2T9
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Country
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Canada
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Tel
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+1 403 944 1788
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Fax
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+1 403 944 2844
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Email
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rsigal@ucalgary.ca
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Sponsor
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Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
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Address
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725 Parkdale Avenue
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City/town
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Ottawa
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Zip/Postcode
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K1Y 4E9
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Country
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Canada
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Sponsor website:
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http://www.ohri.ca/
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Date applied
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05/09/2005
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Last edited
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27/01/2010
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Date ISRCTN assigned
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05/09/2005
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