Diabetes Exercise and Lifestyle Trial

Early Phase 1

• Conditions: Diabetes Mellitus

• Registration Number: NCT00877864
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-07
• Study First Posted: 2009-04-08
• Study Start: 2010-02
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-05
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada