Status:
COMPLETED
The Effect of Exercise on Gut Microbiota in Type 2 Diabetic Patients
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Type 2 Diabetes Mellitus
Insulin Sensitivity/Resistance
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ty...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 11 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03380338
Start Date
May 11 2016
End Date
June 29 2017
Last Update
June 3 2019
Active Locations (1)
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1
VU University Medical Center
Amsterdam, North Holland, Netherlands, 1081 HV