- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02388113
Effect of Exercise Frequency on Metabolic Control and Heart Function in Type 2 Diabetes
November 5, 2015 updated by: Norwegian University of Science and Technology
The Effect of Accumulated Versus Traditional Exercise Training on Metabolic Control and Heart Function in Individuals With Type 2 Diabetes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Trondheim, Norway
- Department of Circulation and Diagnostic Imaging
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: accumulated exercise
12 exercise sessions of 10 minutes each week, 2 per day, 1 day rest
|
|
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Active Comparator: traditional exercise
4 exercise sessions of 30 minutes each week, 3 in the training laboratory, 1 at home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
glycosylated hemoglobin (HbA1c)
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Charlotte Ingul, PhD MD, Norwegian University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
March 12, 2015
First Posted (Estimate)
March 13, 2015
Study Record Updates
Last Update Posted (Estimate)
November 6, 2015
Last Update Submitted That Met QC Criteria
November 5, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/1405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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