NCT02257190

Brief Summary

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 reason IW is superior is unknown. This study will look into whether it is the larger peak intensity during IW or if it is the alternating exercise pattern that is responsible for the larger improvements seen. Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:

  1. 1.One hour of rest (Con)
  2. 2.One hour of classical interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW3)
  3. 3.One hour of fast alternating interval walking (repeated cycles of 1 min of fast and 1 min of slow walking; IW1).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

October 1, 2014

Last Update Submit

October 28, 2015

Conditions

Diabetes Mellitus, Type 2

Keywords

Glycemic controlExercise

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    Glycemic control will be measured 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 interventions

Secondary Outcomes (2)

  • Insulin secretion

    Within the first 4 hours after the interventions

  • Insulin sensitivity

    Within the first 4 hours after the interventions

Study Arms (3)

Control (Con)

EXPERIMENTAL

No exercise intervention.

Behavioral: Control

Interval Walking - 3 min intervals (IW3)

EXPERIMENTAL

One hour of classical interval walking exercise (repeated cycles of 3 min of fast and 3 min of slow walking.

Behavioral: IW3

Interval Walking - 1 min intervals (IW1)

EXPERIMENTAL

One hour of fast alternating interval walking exercise (repeated cycles of 3 min of fast and 3 min of slow walking

Behavioral: IW1

Interventions

ControlBEHAVIORAL

One hour of rest.

Also known as: No exercise
Control (Con)
IW3BEHAVIORAL

A one hour exercise bout with repeated cycles of 3 min of fast and 3 min of slow walking

Also known as: 'Classical' interval walking, Interval walking - 3 min intervals
Interval Walking - 3 min intervals (IW3)
IW1BEHAVIORAL

A one hour exercise bout with repeated cycles of 1 min of fast and 1 min of slow walking

Also known as: 'Fast alternating' interval walking, Interval walking - 1 min intervals
Interval Walking - 1 min intervals (IW1)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • Body mass index \> 18 but \< 40 m2/kg
  • Agreement to pause antidiabetic medication from 2 days before to after each trial

You may not qualify if:

  • Pregnancy
  • Smoking
  • Use of exogenous insulin
  • Contraindication to increased levels of physical activity
  • Evidence of thyroid, liver, lung, heart or kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Physical Activity Research (CFAS)

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Jakobsen I, Solomon TP, Karstoft K. The Acute Effects of Interval-Type Exercise on Glycemic Control in Type 2 Diabetes Subjects: Importance of Interval Length. A Controlled, Counterbalanced, Crossover Study. PLoS One. 2016 Oct 3;11(10):e0163562. doi: 10.1371/journal.pone.0163562. eCollection 2016.

    PMID: 27695119DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Kristian Karstoft, MD, PhD

    Centre for Physical Activity Research, Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 6, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

October 1, 2015

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

DK(1)