Contact information
Type
Scientific
Primary contact
Dr Ronald Jeremy Sigal
ORCID ID
Contact details
7th floor
North Tower
Foothills Medical Center
1403 29 Street NW
Calgary
Alberta
T2N 2T9
Canada
+1 403 944 1788
rsigal@ucalgary.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00195884
Protocol/serial number
MCT-44155
Study information
Scientific title
Effects of aerobic exercise, resistance exercise, or both in type 2 diabetes: a randomised trial
Acronym
DARE
Study hypothesis
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.
Ethics approval
Loeb Health Research Institute at the Ottawa Hospital approved on the 25th March 1999
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Type 2 diabetes mellitus
Intervention
Aerobic and resistance exercise training versus none.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
01/04/2001
Overall trial end date
31/03/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
216
Participant exclusion criteria
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
Recruitment start date
01/04/2001
Recruitment end date
31/03/2005
Locations
Countries of recruitment
Canada
Trial participating centre
7th floor, North Tower
Calgary, Alberta
T2N 2T9
Canada
Sponsor information
Organisation
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Sponsor details
725 Parkdale Avenue
Ottawa
K1Y 4E9
Canada
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44155) funding for all remaining subjects
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Canadian Diabetes Association (Canada) - funding for first 28 subjects
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Ottawa Interfaculty Grant (Canada) - funding for energy expenditure measurement on first 28 subjects
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17876019
Publication citations
-
Results
Sigal RJ, Kenny GP, Boulé NG, Wells GA, Prud'homme D, Fortier M, Reid RD, Tulloch H, Coyle D, Phillips P, Jennings A, Jaffey J, Effects of aerobic training, resistance training, or both on glycemic control in type 2 diabetes: a randomized trial., Ann. Intern. Med., 2007, 147, 6, 357-369.