Status:
COMPLETED
Resistance Exercise in Already-active Diabetic Individuals (READI) Trial
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Diabetes
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
The purpose of the READI tiral is to examine the effects of resistance training (weight training) on the blood sugar control of aerobically active individuals with Type 1 Diabetes.
Detailed Description
Background: Juvenile-onset type 1 (insulin-dependent) diabetes is associated with a 15 year reduction in life expectancy, primarily due to cardiovascular disease (CVD). Poor blood glucose (glycemic) c...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus as defined by the 2003 CDA guidelines with duration \≥1 year, requiring insulin therapy starting within one year of diagnosis and continuously thereafter.
- Male or female, age \≥16 years, HbA1c 0.066-0.099 (normal non-diabetic range 0.040-0.060).
- Habitual performance during the previous 4 months of exercise \≥3 times per week, including at least 90 minutes per week of vigourous aerobic exercise (of sufficient intensity to cause sweating; e.g. jogging, soccer, basketball, racquet sports), and/or \≥150 minutes per week of aerobic exercise of at least moderate intensity (e.g. brisk walking, moderate-paced bicycling) but no resistance training. Subjects must agree to maintain their habitual volume and intensity of aerobic activity during run-in and intervention periods, minimizing variation due to seasons, but they will be permitted to vary specific exercises chosen.
- Willingness and ability to work closely with the study physicians, nurse and dietitian and follow their recommendations for insulin therapy and adjustments of diet.
Exclusion
- Participation during the previous 4 months 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 \>35 kg/m2, or weight \>147 kg (exceeding capacity of DEXA or CT scanners)
- Fasting serum c-peptide \0.2 nmol/l.
- Increase or decrease of \5% of body weight during the previous two months.
- 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 \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.
- Ischemic ECG changes during baseline maximal cardiopulmonary stress test, unless subsequently cleared for participation by a cardiologist after appropriate investigation.
- Low aerobic fitness: Aerobic fitness more than 15% below the mean for age and gender, based on baseline maximal treadmill exercise test. This criterion is included in order to reduce likelihood of candidates entering the trial by exaggerating their habitual activity. Very few people engaging in regular aerobic activity would have such low treadmill performance.
- Unwillingness to sign informed consent.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00410436
Start Date
October 1 2006
End Date
June 1 2012
Last Update
February 27 2013
Active Locations (3)
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1
University of Calgary
Calgary, Alberta, Canada, T3R 0X7
2
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1H 7W9
3
University Health Network
Toronto, Ontario, Canada, M5G 2C4