Interval-training and Appetite Regulation in Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CON
CW
IW
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Exercise, Appetite, Energy intake
Eligibility Criteria
Inclusion Criteria:
- Type 2 Diabetes Mellitus
- BMI > 25
Exclusion Criteria:
- Pregnancy
- Smoking
- Contraindication to increased levels of physical activity
- Eating disorder
- Insulin dependence
Sites / Locations
- Center for Physical Activity Research (CFAS)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
CON
CW
IW
Arm Description
Control (CON).
Continuous Walking (CW).
Interval Walking (IW).
Outcomes
Primary Outcome Measures
Ad-libitum meal energy intake
Subjects will receive a standardized ad-libitum meal and energy intake will be assessed
Secondary Outcome Measures
Free-living energy intake
Subjects will complete diet records for 32 hours following the ad-libitum meal and energy intake will be assessed.
Appetite-related hormones
Appetite-related hormones (insulin, ghrelin, leptin, cholecyctokinin, PYY) will be analysed in blood samples collected regularly during the liquid mixed-meal tolerance test following the intervention
Satiety
Satiety questionaires will be completed at regular intervals after the intervention
Full Information
NCT ID
NCT02592616
First Posted
October 28, 2015
Last Updated
June 21, 2016
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02592616
Brief Title
Interval-training and Appetite Regulation in Patients With Type 2 Diabetes
Official Title
Interval-training and Appetite Regulation in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
One hour of rest (CON)
One hour of interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW)
One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.
After the interventions subjects will undergo a liquid mixed meal tolerance test (450 kCal), with regular measurements of appetite-related hormones (insulin, ghrelin, Leptin, Cholecystokinin, PYY). Three hours into the mixed meal tolerance test, a standardised ad-libitum meal test will be served and intake will recorded. Free-living energy intake via food records will be assessed during the following 32 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Exercise, Appetite, Energy intake
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CON
Arm Type
Experimental
Arm Description
Control (CON).
Arm Title
CW
Arm Type
Experimental
Arm Description
Continuous Walking (CW).
Arm Title
IW
Arm Type
Experimental
Arm Description
Interval Walking (IW).
Intervention Type
Behavioral
Intervention Name(s)
CON
Intervention Description
No exercise intervention.
Intervention Type
Behavioral
Intervention Name(s)
CW
Intervention Description
One hour of continuous walking on a treadmill.
Intervention Type
Behavioral
Intervention Name(s)
IW
Intervention Description
One hour of interval (repeated cycles of 3 minutes of fast and 3 minutes of slow) walking on treadmill.
Primary Outcome Measure Information:
Title
Ad-libitum meal energy intake
Description
Subjects will receive a standardized ad-libitum meal and energy intake will be assessed
Time Frame
Initiated 3 hours after the intervention
Secondary Outcome Measure Information:
Title
Free-living energy intake
Description
Subjects will complete diet records for 32 hours following the ad-libitum meal and energy intake will be assessed.
Time Frame
For 32 hours following the ad-libitum meal.
Title
Appetite-related hormones
Description
Appetite-related hormones (insulin, ghrelin, leptin, cholecyctokinin, PYY) will be analysed in blood samples collected regularly during the liquid mixed-meal tolerance test following the intervention
Time Frame
Regularly during the 3 hours following the intervention
Title
Satiety
Description
Satiety questionaires will be completed at regular intervals after the intervention
Time Frame
Regular assessments for 36 hours following the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 Diabetes Mellitus
BMI > 25
Exclusion Criteria:
Pregnancy
Smoking
Contraindication to increased levels of physical activity
Eating disorder
Insulin dependence
Facility Information:
Facility Name
Center for Physical Activity Research (CFAS)
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Interval-training and Appetite Regulation in Patients With Type 2 Diabetes
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