Optimization of Interval-training in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The time spend with high-intensity (fast) walking is considered to be responsible for the improvements seen, whereas the time spend with low-intensity (slow) walking is considered less important. This study will assess if IW with maintained fast walking time duration but reduced total time duration (i.e. reduced slow walking time duration) is equally effective as IW with a normal time duration. Subjects with type 2 diabetes will be included in a crossover, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions: Sixty minutes of rest (CON) Sixty minutes of classical interval walking (repeated cycles of 3 minutes of fast and 3 minutes of slow walking; IW-60) Fourty-five minutes of time-reduced interval walking (repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking; IW-45). After the interventions subjects will undergo a standardized mixed meal tolerance test with assessment of glycemic control.

Official Title
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Optimization of Interval-training in Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: CON
* Behavioral: IW-60
* Behavioral: IW-45


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control (CON)<br>No exercise intervention. | Behavioral: CON<br> <br> |
| Experimental: Normal Interval Walking (IW-60).<br>Sixty minutes with repeated cycles of 3 minutes of fast and 3 minutes of slow walking on a treadmill | Behavioral: IW-60<br> <br> |
| Experimental: Time-reduced Interval Walking (IW-45)<br>Forty-five minutes with repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking on a treadmill | Behavioral: IW-45<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Glycemic control will be assessed after each intervention. Subjects will receive a standardized mixed meal tolerance test (MMTT), and blood glucose values will be obtained during the test. | Within the first 4 hours after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Matsuda insulin sensitivity index | From the measurements of glucose and insulin during the MMTT, the Matsuda index of insulin sensitivity will be assessed. | Within the first 4 hours after the intervention | 
| Stumvoll insulin sensitivity index | From the measurements of glucose and insulin during the MMTT, the Stumvoll index of insulin sensitivity will be assessed. | Within the first 4 hours after the intervention | 
| Cederholm insulin sensitivity index | From the measurements of glucose and insulin during the MMTT, the Cederholm index of insulin sensitivity will be assessed. | Within the first 4 hours after the intervention | 
| HOMA-2 insulin resistance index | From the measurements of glucose and insulin during the MMTT, the HOMA-2 index of insulin resistance will be assessed. | Within the first 4 hours after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic control, exercise, Interval Training