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The Acute Effect of Interval-walking (acute IWS)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Interval Walking
Continuous walking
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Glycemic control, excess post-exercise oxygen consumption

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diabetes mellitus, type 2

Exclusion Criteria:

  • Smoking
  • Pregnancy
  • insulin dependence
  • Contraindication to physical activity (as judged by medical history and screening)
  • Evidence of thyroid, liver, lung, kidney or heart disease

Sites / Locations

  • Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Interval Walking

Continuous walking

Arm Description

No exercise (control experiment)

A one hour interval walking exercise bout

A one hour continuous walking exercise bout

Outcomes

Primary Outcome Measures

Glycemic control
Glycemic control will be assessed after a one hour specific exercise intervention (control/continuous walking/interval walking) in a controlled setting (a mixed meal tolerance test). Moreover, glycemic control will be assessed during the following 2 days in a free-living environment, using continuous glucose monitoring systems.

Secondary Outcome Measures

Excess post-exercise oxygen consumption (EPOC)
EPOC will be assessed during the hours following the before-mentioned specific exercise bouts using the indirect calorimetry ventilated hood technique.

Full Information

First Posted
June 28, 2013
Last Updated
February 26, 2014
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01987258
Brief Title
The Acute Effect of Interval-walking
Acronym
acute IWS
Official Title
The Acute Effect of Interval-walking
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Four months of interval walking training (IWT) is superior to energy-expenditure matched continuous walking training (CWT) with regards to weight loss and improvements in glycemic control. The reason for this is unclear. One potential explanation for the differential outcome in weight loss is excess post-exercise oxygen consumption (EPOC), which is defined as the elevated oxygen consumption measured during the hours following an exercise bout. A large EPOC means greater energy expenditure which, if energy intake does not change, leads to a greater weight loss. This weight loss may subsequently improve glycemic control Aim 1: To assess the effect of an acute bout of IWT vs. an acute bout of CWT on glycemic control in type 2 diabetics and to assess mechanisms responsible for differences (if any). It is hypothesised that IWT will be more advantageous for improving glycemic control. Aim 2: To examine the effect of an acute bout of IWT vs. an acute bout of CWT on EPOC. It is hypothesised that IWT will produce an EPOC of larger magnitude than CWT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Glycemic control, excess post-exercise oxygen consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No exercise (control experiment)
Arm Title
Interval Walking
Arm Type
Experimental
Arm Description
A one hour interval walking exercise bout
Arm Title
Continuous walking
Arm Type
Experimental
Arm Description
A one hour continuous walking exercise bout
Intervention Type
Behavioral
Intervention Name(s)
Interval Walking
Other Intervention Name(s)
Interval exercise, Interval training
Intervention Type
Behavioral
Intervention Name(s)
Continuous walking
Other Intervention Name(s)
Continuous exercise, Continuous training
Primary Outcome Measure Information:
Title
Glycemic control
Description
Glycemic control will be assessed after a one hour specific exercise intervention (control/continuous walking/interval walking) in a controlled setting (a mixed meal tolerance test). Moreover, glycemic control will be assessed during the following 2 days in a free-living environment, using continuous glucose monitoring systems.
Time Frame
Will be assessed immediately after the intervention using a mixed meal tolerance test (duration: 5 hours) followed by continuous glucose monitoring (duration: 48 hours).
Secondary Outcome Measure Information:
Title
Excess post-exercise oxygen consumption (EPOC)
Description
EPOC will be assessed during the hours following the before-mentioned specific exercise bouts using the indirect calorimetry ventilated hood technique.
Time Frame
Will be assessed immediately after the intervention using a ventilated hood (duration: 5 hours).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes mellitus, type 2 Exclusion Criteria: Smoking Pregnancy insulin dependence Contraindication to physical activity (as judged by medical history and screening) Evidence of thyroid, liver, lung, kidney or heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian Karstoft, MD
Organizational Affiliation
Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641, DK-2100 Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24905068
Citation
Karstoft K, Christensen CS, Pedersen BK, Solomon TP. The acute effects of interval- Vs continuous-walking exercise on glycemic control in subjects with type 2 diabetes: a crossover, controlled study. J Clin Endocrinol Metab. 2014 Sep;99(9):3334-42. doi: 10.1210/jc.2014-1837. Epub 2014 Jun 6.
Results Reference
derived

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The Acute Effect of Interval-walking

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