Diabetes Aerobic and Resistance Exercise (DARE) trial

ISRCTN	ISRCTN32261256
DOI	https://doi.org/10.1186/ISRCTN32261256
ClinicalTrials.gov (NCT)	NCT00195884
Protocol serial number	MCT-44155
Sponsor	Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44155) funding for all remaining subjects, Canadian Diabetes Association (Canada) - funding for first 28 subjects, University of Ottawa Interfaculty Grant (Canada) - funding for energy expenditure measurement on first 28 subjects

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

7th floor, North Tower
Foothills Medical Center
1403 29 Street NW
Calgary, Alberta
T2N 2T9
Canada

Phone	+1 403 944 1788
Email	rsigal@ucalgary.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/03/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/09/2007		Yes	No