Optimization of Interval-training in Patients With Type 2 Diabetes

June 21, 2016 updated by: Anders Rasmussen Rinnov, Rigshospitalet, Denmark

A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The time spend with high-intensity (fast) walking is considered to be responsible for the improvements seen, whereas the time spend with low-intensity (slow) walking is considered less important.

This study will assess if IW with maintained fast walking time duration but reduced total time duration (i.e. reduced slow walking time duration) is equally effective as IW with a normal time duration.

Subjects with type 2 diabetes will be included in a crossover, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:

  1. Sixty minutes of rest (CON)
  2. Sixty minutes of classical interval walking (repeated cycles of 3 minutes of fast and 3 minutes of slow walking; IW-60)
  3. Fourty-five minutes of time-reduced interval walking (repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking; IW-45).

After the interventions subjects will undergo a standardized mixed meal tolerance test with assessment of glycemic control.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • Center for Physical Activity Research (CFAS)

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • BMI > 25

Exclusion Criteria:

  • Pregnancy
  • Smoking
  • Contraindication to increased levels of physical activity
  • Eating disorder
  • Insulin dependence

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control (CON)
No exercise intervention.
Behavioral: CON
Experimental: Normal Interval Walking (IW-60).
Sixty minutes with repeated cycles of 3 minutes of fast and 3 minutes of slow walking on a treadmill
Behavioral: IW-60
Experimental: Time-reduced Interval Walking (IW-45)
Forty-five minutes with repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking on a treadmill
Behavioral: IW-45

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: Within the first 4 hours after the intervention
Glycemic control will be assessed after each intervention. Subjects will receive a standardized mixed meal tolerance test (MMTT), and blood glucose values will be obtained during the test.
Within the first 4 hours after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Matsuda insulin sensitivity index
Time Frame: Within the first 4 hours after the intervention
From the measurements of glucose and insulin during the MMTT, the Matsuda index of insulin sensitivity will be assessed.
Within the first 4 hours after the intervention
Stumvoll insulin sensitivity index
Time Frame: Within the first 4 hours after the intervention
From the measurements of glucose and insulin during the MMTT, the Stumvoll index of insulin sensitivity will be assessed.
Within the first 4 hours after the intervention
Cederholm insulin sensitivity index
Time Frame: Within the first 4 hours after the intervention
From the measurements of glucose and insulin during the MMTT, the Cederholm index of insulin sensitivity will be assessed.
Within the first 4 hours after the intervention
HOMA-2 insulin resistance index
Time Frame: Within the first 4 hours after the intervention
From the measurements of glucose and insulin during the MMTT, the HOMA-2 index of insulin resistance will be assessed.
Within the first 4 hours after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

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, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15008542 - 2

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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