Clinical trial NCT03380338: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Insulin Sensitivity/Resistance
Keywords: Gut microbiota
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2017-12-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Changes in gut microbiota composition upon exercise
timeFrame: At baseline, after 7 weeks, after 13 weeks
measure: Change in insulin senistivity
timeFrame: Before and after exercise, i.e. from first visit (0 weeks) untill last visit (13 weeks)
measure: Change in capillary recruitment
timeFrame: Before and after exercise, i.e. from first visit (0 weeks) untill last visit (13 weeks)
Secondary outcomes:
measure: Changes in resting energy expenditure
timeFrame: Before and after exercise
measure: Changes in continous cardiovascular monitoring
timeFrame: Before and after exercise
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: Noord-Holland
Study officials:
References: