NCT02601482

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 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. 1.Sixty minutes of rest (CON)
  2. 2.Sixty minutes of classical interval walking (repeated cycles of 3 minutes of fast and 3 minutes of slow walking; IW-60)
  3. 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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

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

Timeline
Completed

Started Oct 2015

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

November 4, 2015

Last Update Submit

June 21, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

Glycemic controlexerciseInterval Training

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    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 Outcomes (4)

  • Matsuda insulin sensitivity index

    Within the first 4 hours after the intervention

  • Stumvoll insulin sensitivity index

    Within the first 4 hours after the intervention

  • Cederholm insulin sensitivity index

    Within the first 4 hours after the intervention

  • HOMA-2 insulin resistance index

    Within the first 4 hours after the intervention

Study Arms (3)

Control (CON)

EXPERIMENTAL

No exercise intervention.

Behavioral: CON

Normal Interval Walking (IW-60).

EXPERIMENTAL

Sixty minutes with repeated cycles of 3 minutes of fast and 3 minutes of slow walking on a treadmill

Behavioral: IW-60

Time-reduced Interval Walking (IW-45)

EXPERIMENTAL

Forty-five minutes with repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking on a treadmill

Behavioral: IW-45

Interventions

CONBEHAVIORAL
Control (CON)
IW-60BEHAVIORAL
Normal Interval Walking (IW-60).
IW-45BEHAVIORAL
Time-reduced Interval Walking (IW-45)

Eligibility Criteria

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

You may qualify if:

  • Type 2 Diabetes Mellitus
  • BMI \> 25

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Physical Activity Research (CFAS)

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

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

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 10, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

June 22, 2016

Record last verified: 2016-06

Locations

DK(1)