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NCT02388113 Clinical Trial

Effect of Exercise Frequency on Metabolic Control and Heart Function in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
The Effect of Accumulated Versus Traditional Exercise Training on Metabolic Control and Heart Function in Individuals With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02388113
Other study ID # 2014/1405
Secondary ID
Status Completed
Phase N/A
First received March 9, 2015
Last updated November 5, 2015
Start date October 2014
Est. completion date November 2015

Study information
Verified date November 2015
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

This study will compare two interventions with the same exercise intensities and caloric expenditure but with different exercise frequency, on metabolic control and other risk factors in individuals with type 2 diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date November 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- type 2 diabetes

Exclusion Criteria:

- insulin treatment

- severe chronic diabetic complications

- liver dysfunction

- kidney dysfunction

- inflammatory diseases

- heart failure

- myocardial ischemia

- major cardiovascular event history

- physical exercise more than current guidelines for type 2 diabetes

- inability to exercise

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• accumulated exercise

• traditional exercise

Locations
Country Name City State
Norway Department of Circulation and Diagnostic Imaging Trondheim

Sponsors (1)
Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary glycosylated hemoglobin (HbA1c) The measured HbA1c level consists of average blood glucose by 50% from the last month, 25% from the previous month, and 25% by the two first previous months. Analysis: standard procedure of St Olavs Hospital. 12 weeks No
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