Diabetes Aerobic and Resistance Exercise (DARE) trial

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN32261256
• Lead Sponsor: Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 216

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1.Change in health related quality of life<br>2. Nontraditional cardiovascular risk factors: Apo-B, Apo-A1, high-sensitivity C-reactive protein, LDL particle diameter, estimated insulin resistance <br>3. Blood pressure<br>4. Lipid concentrations<br>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)<br>6. Resting metabolic rate