Interval-training and Appetite Regulation in Patients With Type 2 Diabetes

Study Overview
=================
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.

Official Title
-----------------
Interval-training and Appetite Regulation in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: CON
* Behavioral: CW
* Behavioral: IW


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CON<br>Control (CON). | Behavioral: CON<br>* No exercise intervention.<br>|
| Experimental: CW<br>Continuous Walking (CW). | Behavioral: CW<br>* One hour of continuous walking on a treadmill.<br>|
| Experimental: IW<br>Interval Walking (IW). | Behavioral: IW<br>* One hour of interval (repeated cycles of 3 minutes of fast and 3 minutes of slow) walking on treadmill.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free-living energy intake | Subjects will complete diet records for 32 hours following the ad-libitum meal and energy intake will be assessed. | For 32 hours following the ad-libitum meal. | 
| 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 | Regularly during the 3 hours following the intervention | 
| Satiety | Satiety questionaires will be completed at regular intervals after the intervention | Regular assessments for 36 hours following the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Appetite, Energy intake