Diabetes Aerobic and Resistance Exercise (DARE) trial
ISRCTN | ISRCTN32261256 |
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DOI | https://doi.org/10.1186/ISRCTN32261256 |
ClinicalTrials.gov number | NCT00195884 |
Secondary identifying numbers | MCT-44155 |
- Submission date
- 05/09/2005
- Registration date
- 05/09/2005
- Last edited
- 27/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ronald Jeremy Sigal
Scientific
Scientific
7th floor, North Tower
Foothills Medical Center
1403 29 Street NW
Calgary, Alberta
T2N 2T9
Canada
Phone | +1 403 944 1788 |
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rsigal@ucalgary.ca |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Effects of aerobic exercise, resistance exercise, or both in type 2 diabetes: a randomised trial |
Study acronym | DARE |
Study objectives | 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(s) | Loeb Health Research Institute at the Ottawa Hospital approved on the 25th March 1999 |
Health condition(s) or problem(s) studied | Type 2 diabetes mellitus |
Intervention | Aerobic and resistance exercise training versus none. |
Intervention type | Other |
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 study start date | 01/04/2001 |
Completion date | 31/03/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 216 |
Key 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 |
Key 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 |
Date of first enrolment | 01/04/2001 |
Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
7th floor, North Tower
Calgary, Alberta
T2N 2T9
Canada
T2N 2T9
Canada
Sponsor information
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Research organisation
Research organisation
725 Parkdale Avenue
Ottawa
K1Y 4E9
Canada
Website | http://www.ohri.ca/ |
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https://ror.org/03c62dg59 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44155) funding for all remaining subjects
No information available
Canadian Diabetes Association (Canada) - funding for first 28 subjects
No information available
University of Ottawa Interfaculty Grant (Canada) - funding for energy expenditure measurement on first 28 subjects
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 18/09/2007 | Yes | No |