Interval-training in Type 2 Diabetics

Study Overview
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Brief Summary
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Interval training is superior to continuous training for improving glycemic control, hereunder glycemic variability and -spikes. However, the underlying mechanisms and the clinical impact is at present unknown. The overall objective of this project is to determine the mechanisms underlying aeroic interval-training-induced reductions in glycemic variability and -spikes, and the impact on levels of systemic inflammation in type 2 diabetes patients. It is hypothesized that aerobic interval training reduces glycemic variability and -spikes more than continuous training due to larger improvements in both peripheral insulin sensitivity and the mass action effect of glucose. Moreover, it is hypothesized that these reductions in glycemic variability and -spikes also reduces systemic inflammation.

Official Title
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Interval-training in Type 2 Diabetics - Mechanisms Behind Increased Glucose Disposal and Effects on Systemic Inflammation

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Control
* Behavioral: Continuous walking
* Behavioral: Interval walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus BMI >18 but <40 kg/m2 Exclusion Criteria: Pregnancy Smoking Contraindication to increased levels of physical activity More than moderate levels of physical activity (>90 min/week) of maximally moderate intensity Insulin dependence Thyroid, liver, lung, heart or kidney disease, with the need for treatment

Ages Eligible for Study
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Minimum Age: 40 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Control intervention: Subjects will continue their life unaltered during the 14 days intervention period | Behavioral: Control<br> <br> * Other names: CON;|
| Experimental: Continuous walking<br>Training intervention: Subjects will perform continuous walking for one hour per day at every weekday during the 14 days intervention period | Behavioral: Continuous walking<br> <br> * Other names: CWT;|
| Experimental: Interval Walking<br>Training intervention: Subjects will perform interval walking for one hour per day at every weekday during the 14 days intervention period. Interval walking will be performed as repeated cycles of three minutes of slow and hree minutes of fast walking during the entire training session | Behavioral: Interval walking<br> <br> * Other names: IWT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Glycemic control incl. glycemic variability and -spikes, will be measured with continuous glucose monitoring over 24 hours during standardized dietary intake before and after each intervention. | Change from baseline at 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary isoprostanes as a measure of systemic inflammation | Systemic inflammation will be measured as isoprostanes in urine collected over 24 hours. The changes in glycemic control (Outcome 1), will be correlated with the changes in systemic inflammation. | Change from baseline at 14 days | 
| Rate of dissappearance during a 2-step (pancreatic + hyperinsulinemic) hyperglycemic clamp, as a measure of glucose effectiveness + insulin sensitivity | A 2-step (pancreatic + hyperinsulinemic) hyperglycemic clamp will be performed before and after each intervention, to assess the mechanisms behind the intervention-induced improvements in glycemic control. In this way, the intervention-induced effects on glucose effectiveness and insulin sensitivity will be assessed. | Change from baseline at 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Training, Interval training, Systemic inflammation, Glucose disposal, Insulin sensitivity, Glucose effectiveness