- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877864
Diabetes Exercise and Lifestyle Trial (DEAL)
August 4, 2011 updated by: University of Calgary
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
- 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
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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2T 5C7
- University of Calgary
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
|
No exercise program provided by the study
|
Active Comparator: 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
|
Active Comparator: High volume combined A/R exercise, printouts, pedometers
High volume combined aerobic/resistance 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
|
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
|
Printed PA information, pedometers and step log group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome will be A1c at the end of 6 months supervised exercise period.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ron Sigal, MD, University of Calgary
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
April 6, 2009
First Submitted That Met QC Criteria
April 7, 2009
First Posted (Estimate)
April 8, 2009
Study Record Updates
Last Update Posted (Estimate)
August 5, 2011
Last Update Submitted That Met QC Criteria
August 4, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEAL- 22251
- CHREB 22251
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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