Diabetes Exercise and Lifestyle Trial
DEAL
2 other identifiers
interventional
26
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 diabetes-mellitus
Started Feb 2010
Typical duration for early_phase_1 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2009
CompletedFirst Posted
Study publicly available on registry
April 8, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 5, 2011
August 1, 2011
2.8 years
April 6, 2009
August 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome will be A1c at the end of 6 months supervised exercise period.
6 months
Study Arms (6)
High volume combined aerobic/resistance exercise
ACTIVE COMPARATORLow volume combined aerobic/resistance exercise
ACTIVE COMPARATORLow volume combined aerobic/resistance exercise
High volume combined A/R exercise, printouts, pedometers
ACTIVE COMPARATORHigh volume combined aerobic/resistance exercise, printouts, pedometers
Low volume combined A/R exercise, printouts, pedometers
ACTIVE COMPARATORLow volume combined aerobic/resistance exercise, printouts, pedometers
Printed PA information, pedometers and step log group
ACTIVE COMPARATORPrinted physical activity information, pedometers and step log group
Control
PLACEBO COMPARATORInterventions
High volume combined aerobic/resistance exercise
Low volume combined aerobic/resistance exercise
High volume combined aerobic/resistance exercise, printouts, pedometers
Low volume combined aerobic/resistance exercise, printouts, pedometers
Printed PA information, pedometers and step log group
Eligibility Criteria
You may qualify if:
- type 2 diabetes
- A1c 0.700-0.099
- ability to read and write English
- signed ICF
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Calgary
Calgary, Alberta, T2T 5C7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Sigal, MD
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 6, 2009
First Posted
April 8, 2009
Study Start
February 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 5, 2011
Record last verified: 2011-08