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Diabetes Exercise and Lifestyle Trial (DEAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00877864
First received: April 6, 2009
Last updated: August 4, 2011
Last verified: August 2011
History of Changes
  Purpose

The objective of this study is to determine the effects of supervised combined aerobic and resistance training, and the effects of stage-matched written materials delivered by mail or internet, alone or in combination, on glycemic control as reflected in A1C (glycated hemoglobin).


Condition Intervention Phase
Diabetes Mellitus
 Behavioral: High volume combined aerobic/resistance exercise
Behavioral: Low volume combined aerobic/resistance exercise
Behavioral: High volume combined A/R exercise, printouts, pedometers
Behavioral: Low volume combined A/R exercise, printouts, pedometers
Behavioral: Printed PA information, pedometers and step log group
Behavioral: Control
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Diabetes Exercise and Lifestyle Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • The primary outcome will be A1c at the end of 6 months supervised exercise period. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: February 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High volume combined aerobic/resistance exercise Behavioral: High volume combined aerobic/resistance exercise
High volume combined aerobic/resistance exercise
Active Comparator: Low volume combined aerobic/resistance exercise
Low volume combined aerobic/resistance exercise
 Behavioral: Low volume combined aerobic/resistance exercise
Low volume combined aerobic/resistance exercise
Active Comparator: High volume combined A/R exercise, printouts, pedometers
High volume combined aerobic/resistance exercise, printouts, pedometers
 Behavioral: High volume combined A/R exercise, printouts, pedometers
High volume combined aerobic/resistance exercise, printouts, pedometers
Active Comparator: Low volume combined A/R exercise, printouts, pedometers
Low volume combined aerobic/resistance exercise, printouts, pedometers
 Behavioral: Low volume combined A/R exercise, printouts, pedometers
Low volume combined aerobic/resistance exercise, printouts, pedometers
Active Comparator: Printed PA information, pedometers and step log group
Printed physical activity information, pedometers and step log group
 Behavioral: Printed PA information, pedometers and step log group
Printed PA information, pedometers and step log group
Placebo Comparator: Control Behavioral: Control
No exercise program provided by the study

Detailed Description:

Background Rationale: Structured, supervised exercise programs involving aerobic exercise, resistance exercise or their combination resulted in significant improvements in glycemic control in type 2 diabetes. It has also been shown that programs which include a psychological/behavioral component in addition to diet and exercise have been most effective for long-term treatment of obesity in diabetes. The supervised exercise program has stronger evidence for improvement of metabolic control and cardiac risk, but its longer-term sustainability has not been demonstrated, and it is relatively costly. A stage-matched printed materials/pedometer intervention has been shown to increase physical activity over a longer period of time, and likely at a lower per-patient cost than the supervised exercise intervention, but with less evidence for improvement of metabolic control.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • type 2 diabetes
  • A1c 0.700-0.099
  • ability to read and write English
  • signed ICF

Exclusion Criteria:

  • participation in previous 6 months in exercise > 2 times per week for at least 20 min per session
  • insulin therapy changes in medication for diabetes, BP or Lipids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877864

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2T 5C7
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Ron Sigal, MD University of Calgary
  More Information

No publications provided

Responsible Party: Dr. Ron Sigal, University of Calgary
ClinicalTrials.gov Identifier: NCT00877864     History of Changes
Other Study ID Numbers: DEAL- 22251, CHREB 22251
Study First Received: April 6, 2009
Last Updated: August 4, 2011
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of Calgary:
diabetes
exercise
printed materials

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013