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

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

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

      • Trondheim, Norway
        • Department of Circulation and Diagnostic Imaging

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
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

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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