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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380338
• Other study ID #: Bootcamp2
• Status: Completed
• Phase: N/A
• Start date: May 11, 2016
• Est. completion date: June 29, 2017

Study information

• Verified date: May 2019
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 29, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Insulin Sensitivity/Resistance
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Combined aerobic and strength exercise

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
VU University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gut microbiota composition upon exercise	alfa-diversity, beta-diversity	At baseline, after 7 weeks, after 13 weeks
Primary	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)
Primary	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	Changes in resting energy expenditure	Indirect calorimetry	Before and after exercise
Secondary	Changes in continous cardiovascular monitoring		Before and after exercise