ClinicalTrials.Veeva

Menu

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

A

Amsterdam UMC, location VUmc

Status

Completed

Conditions

Insulin Sensitivity/Resistance
Type 2 Diabetes Mellitus

Treatments

Behavioral: Combined aerobic and strength exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03380338
Bootcamp2

Details and patient eligibility

About

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.

Full 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

Enrollment

15 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Exercise program
Experimental group
Description:
Twice weekly exercise program, combined aerobic and strenght training
Treatment:
Behavioral: Combined aerobic and strength exercise

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems