Diabetes Exercise and Lifestyle Trial (DEAL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Calgary.
Recruitment status was  Active, not recruiting
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
  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:


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
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: 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 September 18, 2014