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Clinical Trials/NCT00877864
NCT00877864
Unknown
Early Phase 1

Diabetes Exercise and Lifestyle Trial

University of Calgary1 site in 1 country26 target enrollmentFebruary 2010

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
University of Calgary
Enrollment
26
Locations
1
Primary Endpoint
The primary outcome will be A1c at the end of 6 months supervised exercise period.
Last Updated
14 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
December 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

The primary outcome will be A1c at the end of 6 months supervised exercise period.

Time Frame: 6 months

Study Sites (1)

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