Type 1 Diabetes Aerobic and Resistance Exercise (T1-DARE)
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 Diabetes, Resistance Exercise, Aerobic Exercise, Exercise & Disease, Exercise, Diabetes
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes mellitus as defined by the 2003 CDA guidelines (16) requiring insulin therapy starting within one year of diagnosis and continuously thereafter Male or female, age 16-45 years, A1c 0.066-0.090 Physically inactive (see exclusion criteria below) Willingness and ability to work closely with the study physicians, nurse and dietitian and follow intensive diabetes therapy including carbohydrate counting, glucose monitoring ≥ 4 times per day, and intensive insulin therapy--either by multiple daily injections (MDI--insulin aspart or lispro before meals and NPH or insulin glargine 1-2X/day) or continuous subcutaneous insulin infusion (CSII) by pump therapy using insulin aspart or lispro for the duration of involvement in the study. CSII will only be an option for those already on CSII prior to entry in the study. Exclusion Criteria: Participation during the previous 4 months in a regular program of exercise or aerobic sports greater than 2 times per week for at least 20 minutes per session, or in any resistance training. Hypoglycemia unawareness, or severe hypoglycemia requiring assistance from another person within the previous 3 months. "Brittle" diabetes, characterized by frequent and unpredictable hypoglycemia (even if not requiring assistance from others) and hyperglycemia. 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. Known or suspected clinically significant gastroparesis. Body mass index less than or equal to 32 kg/m2. Fasting serum c-peptide less than 0.2 nmol/l. Recent significant weight change (increase or decrease of 5% of body weight during the two months before enrollment). An expected requirement within the subsequent 6 months for medications (other than insulin) that will affect glucose metabolism (e.g. corticosteroids). If age < 18 yr, linear growth of 1cm during the previous year. Significant renal disease: serum creatinine greater than 200 mEq/l. or proteinuria > 1 g/24 hours. Uncontrolled hypertension: BP > 150 mm Hg systolic or > 95 mm Hg diastolic in a sitting position. Other illness, judged by the patient or investigators to make participation in this study inadvisable. Cognitive deficit resulting in inability to understand or comply with instructions. Pregnancy at the start of the study, or intention to become pregnant in the next year. Inability to communicate in English or French. Unwillingness to sign informed consent.
Sites / Locations
- Ottawa Health Research Institute
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1
2
resistance exercise
Aerobic and Resistance exercise