Lifestyle Intervention in Patients With Diabetes Type 2 and the Association With the Gut Microbiota
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Amsterdam UMC, location VUmc
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in insulin senistivity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Erik Serne
Principal Investigator
Amsterdam UMC, location VUmc
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)
Outcomes
Primary Outcomes
Change in insulin senistivity
Time Frame: 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
Time Frame: 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
Time Frame: At baseline, after 7 weeks, after 13 weeks
alfa-diversity, beta-diversity
Secondary Outcomes
- Changes in resting energy expenditure(Before and after exercise)
- Changes in continous cardiovascular monitoring(Before and after exercise)