Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/09/2005
Date assigned
05/09/2005
Last edited
27/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ohri.ca/

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17876019

Publication citations

  1. 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.

Additional files

Editorial Notes