Diabetes Aerobic and Resistance Exercise (DARE) trial

ISRCTN ISRCTN32261256
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

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffects of aerobic exercise, resistance exercise, or both in type 2 diabetes: a randomised trial
Study acronymDARE
Study objectivesTo 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) studiedType 2 diabetes mellitus
InterventionAerobic and resistance exercise training versus none.
Intervention typeOther
Primary outcome measureChange 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 measures1.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 date01/04/2001
Completion date31/03/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants216
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2001
Date of final enrolment31/03/2005

Locations

Countries of recruitment

  • Canada

Study participating centre

7th floor, North Tower
Calgary, Alberta
T2N 2T9
Canada

Sponsor information

Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Research organisation

725 Parkdale Avenue
Ottawa
K1Y 4E9
Canada

Website http://www.ohri.ca/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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