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

Primary Purpose

Type 2 Diabetes Mellitus, Insulin Sensitivity/Resistance

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Combined aerobic and strength exercise
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Gut microbiota

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VU University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise program

Arm Description

Twice weekly exercise program, combined aerobic and strenght training

Outcomes

Primary Outcome Measures

Changes in gut microbiota composition upon exercise
alfa-diversity, beta-diversity
Change in insulin senistivity
Rate of disappearance measured by the hyperinsulinemic-euglycemic clamp with stable glucose isotopes.
Change in capillary recruitment
Insulin-induced capillary recruitment in skeletal muscle and heart

Secondary Outcome Measures

Changes in resting energy expenditure
Indirect calorimetry
Changes in continous cardiovascular monitoring

Full Information

First Posted
December 8, 2017
Last Updated
May 30, 2019
Sponsor
Amsterdam UMC, location VUmc
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT03380338
Brief Title
The Effect of Exercise on Gut Microbiota in Type 2 Diabetic Patients
Official Title
Lifestyle Intervention in Patients With Diabetes Type 2 and the Association With the Gut Microbiota
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Insulin Sensitivity/Resistance
Keywords
Gut microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise program
Arm Type
Experimental
Arm Description
Twice weekly exercise program, combined aerobic and strenght training
Intervention Type
Behavioral
Intervention Name(s)
Combined aerobic and strength exercise
Primary Outcome Measure Information:
Title
Changes in gut microbiota composition upon exercise
Description
alfa-diversity, beta-diversity
Time Frame
At baseline, after 7 weeks, after 13 weeks
Title
Change in insulin senistivity
Description
Rate of disappearance measured by the hyperinsulinemic-euglycemic clamp with stable glucose isotopes.
Time Frame
Before and after exercise, i.e. from first visit (0 weeks) untill last visit (13 weeks)
Title
Change in capillary recruitment
Description
Insulin-induced capillary recruitment in skeletal muscle and heart
Time Frame
Before and after exercise, i.e. from first visit (0 weeks) untill last visit (13 weeks)
Secondary Outcome Measure Information:
Title
Changes in resting energy expenditure
Description
Indirect calorimetry
Time Frame
Before and after exercise
Title
Changes in continous cardiovascular monitoring
Time Frame
Before and after exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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

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