Status:
COMPLETED
Type 1 Diabetes Aerobic and Resistance Exercise (T1-DARE)
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
This is a randomized controlled trial evaluating different exercise modalities in previously inactive subjects with type 1 diabetes. The primary objective of this study is to determine the effects of...
Detailed Description
Background: Type 1 diabetes is characterized by complete or near-complete absence of insulin secretion, generally due to autoimmune disease. Cardiovascular disease (CVD) risk in type 1 diabetes is jus...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00148538
Start Date
July 1 2005
End Date
April 1 2012
Last Update
July 23 2019
Active Locations (1)
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1
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1Y 4E9