The Effect of Exercise on Gut Microbiota in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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To investigate whether targeted lifestyle intervention (exercise), induces a change in intestinal fecal microbiota related to improved glycemic control and systemic inflammation in patients with DM type 2.

Detailed Description
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Diet and exercise are the most beneficial lifestyle interventions in patients with diabetes mellitus (DM) type 2, causing an increase in glucose tolerance. One of the mechanisms through which these treatment modalities work might be explained through changes in the gut microbiota. Recent studies show that the chronic inflammatory status causing insulin resistance in DM type 2, is triggered by an increase in circulating bacterial lipopolysaccharide (LPS). Strict lifestyle intervention, such as exercise, so called Diabetes Bootcamp (DB), may manipulate the gut microbiota, reducing circulating LPS, causing an improvement of the insulin-mediated

Official Title
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Lifestyle Intervention in Patients With Diabetes Type 2 and the Association With the Gut Microbiota

Conditions
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Type 2 Diabetes Mellitus, Insulin Sensitivity/Resistance

Intervention / Treatment
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* Behavioral: Combined aerobic and strength exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet the criteria for diabetes type 2 (a random blood sugar of > 11.1 mmol/L and/or a fasting blood sugar lever of >7.0 mmol/L and/or a blood sugar of >11.1 mmol/L two hours after an oral glucose tolerance test and/or an HbA1c level of >47 mmol/mol). Male or female (post-menopausal) Age above 45 years and below 70 years BMI >30 kg/m2 HbA1c < 80 mmol/mol or < 8,6% Subjects must use metformin Stable medication use Stable tension regulation (with or without medication) Subjects should be able to give informed consent Exclusion Criteria: A history of cardiovascular event (Cerebrovascular event, myocardial infarction or pacemaker implantation) Severe-very severe lung emphysema (GOLD stage III-IV) Use of any antibiotics or proton pump inhibitor (PPI) in the past three months Use of any other antidiabetic medication besides metformin (e.g. SU-derivates, insulin) Use of a platelet inhibitor or cumarin derivate during Subjects participated in a lifestyle programme in the past 6 months (diet or exercise)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise program<br>Twice weekly exercise program, combined aerobic and strenght training | Behavioral: Combined aerobic and strength exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gut microbiota composition upon exercise | alfa-diversity, beta-diversity | At baseline, after 7 weeks, after 13 weeks | 
| Change in insulin senistivity | Rate of disappearance measured by the hyperinsulinemic-euglycemic clamp with stable glucose isotopes. | Before and after exercise, i.e. from first visit (0 weeks) untill last visit (13 weeks) | 
| Change in capillary recruitment | Insulin-induced capillary recruitment in skeletal muscle and heart | Before and after exercise, i.e. from first visit (0 weeks) untill last visit (13 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in resting energy expenditure | Indirect calorimetry | Before and after exercise | 
| Changes in continous cardiovascular monitoring |  | Before and after exercise | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut microbiota