NCT01987258

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

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

Timeline
Completed

Started Jun 2013

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

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

Study Start

First participant enrolled

June 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

June 28, 2013

Last Update Submit

February 26, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

Glycemic controlexcess post-exercise oxygen consumption

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (1)

  • Excess post-exercise oxygen consumption (EPOC)

    Will be assessed immediately after the intervention using a ventilated hood (duration: 5 hours).

Study Arms (3)

Control

NO INTERVENTION

No exercise (control experiment)

Interval Walking

EXPERIMENTAL

A one hour interval walking exercise bout

Behavioral: Interval Walking

Continuous walking

EXPERIMENTAL

A one hour continuous walking exercise bout

Behavioral: Continuous walking

Interventions

Interval WalkingBEHAVIORAL
Also known as: Interval exercise, Interval training
Interval Walking
Continuous walkingBEHAVIORAL
Also known as: Continuous exercise, Continuous training
Continuous walking

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus, type 2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24905068DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kristian Karstoft, MD

    Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641, DK-2100 Copenhagen, 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
Administrator

Study Record Dates

First Submitted

June 28, 2013

First Posted

November 19, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations

DK(1)