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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Insulin Sensitivity/Resistance
• Intervention / Treatment: Behavioral: Combined aerobic and strength exercise

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • VU University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise program; Twice weekly exercise program, combined aerobic and strenght training	Behavioral: Combined aerobic and strength exercise

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2016
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Gut microbiota
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperinsulinism; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: Bootcamp2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO