Interval-training and Appetite Regulation in Patients With Type 2 Diabetes
1 other identifier
interventional
14
1 country
1
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.One hour of rest (CON)
- 2.One hour of interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW)
- 3.One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Oct 2015
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
October 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJune 22, 2016
June 1, 2016
8 months
October 28, 2015
June 21, 2016
Conditions
Keywords
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
EXPERIMENTALControl (CON).
CW
EXPERIMENTALContinuous Walking (CW).
IW
EXPERIMENTALInterval Walking (IW).
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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