NCT02592616

Brief Summary

Four months of interval walking (IW) training results in substantial weight loss in opposition to energy-expenditure matched continuous walking (CW) training. The reason for this is unclear. This study will assess if IW leads to greater exercise-induced suppression of appetite and ad libitum food intake compared to CW and no exercise. 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 interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW)
  3. 3.One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.

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
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 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

October 28, 2015

Last Update Submit

June 21, 2016

Conditions

Keywords

ExerciseAppetiteEnergy intake

Outcome Measures

Primary Outcomes (1)

  • Ad-libitum meal energy intake

    Subjects will receive a standardized ad-libitum meal and energy intake will be assessed

    Initiated 3 hours after the intervention

Secondary Outcomes (3)

  • Free-living energy intake

    For 32 hours following the ad-libitum meal.

  • Appetite-related hormones

    Regularly during the 3 hours following the intervention

  • Satiety

    Regular assessments for 36 hours following the intervention

Study Arms (3)

CON

EXPERIMENTAL

Control (CON).

Behavioral: CON

CW

EXPERIMENTAL

Continuous Walking (CW).

Behavioral: CW

IW

EXPERIMENTAL

Interval Walking (IW).

Behavioral: IW

Interventions

CONBEHAVIORAL

No exercise intervention.

CON
CWBEHAVIORAL

One hour of continuous walking on a treadmill.

CW
IWBEHAVIORAL

One hour of interval (repeated cycles of 3 minutes of fast and 3 minutes of slow) walking on treadmill.

IW

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
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 28, 2015

First Posted

October 30, 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