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NCT00877864 Clinical Trial

Diabetes Exercise and Lifestyle Trial

Diabetes Mellitus Clinical Trial

— DEAL  

Official title:
Diabetes Exercise and Lifestyle Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00877864
Other study ID # DEAL- 22251
Secondary ID CHREB 22251
Status Active, not recruiting
Phase Phase 0
First received April 6, 2009
Last updated August 4, 2011
Start date February 2010
Est. completion date December 2012

Study information
Verified date August 2011
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review CommitteeCanada: Health Canada
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 26
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• High volume combined aerobic/resistance exercise
High volume combined aerobic/resistance exercise
• Low volume combined aerobic/resistance exercise
Low volume combined aerobic/resistance exercise
• High volume combined A/R exercise, printouts, pedometers
High volume combined aerobic/resistance exercise, printouts, pedometers
• Low volume combined A/R exercise, printouts, pedometers
Low volume combined aerobic/resistance exercise, printouts, pedometers
• Printed PA information, pedometers and step log group
Printed PA information, pedometers and step log group
• Control
No exercise program provided by the study

Locations
Country Name City State
Canada University of Calgary Calgary Alberta

Sponsors (1)
Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary outcome will be A1c at the end of 6 months supervised exercise period. 6 months Yes
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