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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Insulin Sensitivity/Resistance
• Interventions: Behavioral: Combined aerobic and strength exercise

• Registration Number: NCT03380338
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

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

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

Study Timeline

• Study Start: 2016-05-11
• Primary Completion: 2017-06-29
• Study Completion: 2017-06-29
• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-21
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-30
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise program	Combined aerobic and strength exercise	Twice weekly exercise program, combined aerobic and strenght training

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in resting energy expenditure	Before and after exercise	Indirect calorimetry
Changes in continous cardiovascular monitoring	Before and after exercise

Trial Locations

Locations (1)

VU University Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands