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Resistance Exercise in Already-active Diabetic Individuals (READI) Trial

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00410436
First received: December 8, 2006
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Diabetes
Behavioral: Resistance Exercise
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resistance Exercise in Already-active Diabetic Individuals (READI) Trial

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Change in HbA1c from pre and post-intervention


Secondary Outcome Measures:
  • body composition,LDL particle diameter,apolipoprotein B (Apo-B) [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    measured pre and post exercise intervention

  • apolipoprotein A1 (Apo-A1,Apo-B/Apo-A1 ratio,urinary albumin excretion [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    measured pre and post exercise intervention

  • serum C-reactive protein, [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    measured pre and post intervention


Enrollment: 131
Study Start Date: October 2006
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resistance Training Group
Resistance Training (R) 3X/week progressing to 3 sets, 8 repetitions of 8 exercises at the maximum load that can be lifted 8 times in a controlled manner, maintaining proper form (8RM).
Behavioral: Resistance Exercise
Subjects demonstrating adequate compliance during the run-in period will then be randomized in equal numbers to Resistance Training (R) 3X/week progressing to 3 sets, 8 repetitions of 8 exercises at the maximum load that can be lifted 8 times in a controlled manner, maintaining proper form (8RM), or waiting-list control (C).
Other Name: non applicable
Active Comparator: Control Group
Subjects will not be performing resistance exercise but will continue performing aerobic exercise at the same volume, duration and intensity as they did at baseline.
Behavioral: Resistance Exercise
Subjects demonstrating adequate compliance during the run-in period will then be randomized in equal numbers to Resistance Training (R) 3X/week progressing to 3 sets, 8 repetitions of 8 exercises at the maximum load that can be lifted 8 times in a controlled manner, maintaining proper form (8RM), or waiting-list control (C).
Other Name: non applicable

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410436

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T3R 0X7
Canada, Ontario
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1H 7W9
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Ron Sigal, MD OHRI
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00410436     History of Changes
Other Study ID Numbers: 2005301-01H, 2005783
Study First Received: December 8, 2006
Last Updated: February 25, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Type 1 Diabetes
Resistance Exercise
Aerobic Exercise

ClinicalTrials.gov processed this record on November 20, 2014