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OpenTrials
Completed

NCT Number: NCT03380338

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Combined aerobic and strength exercise

Behavioral

Primary outcomes

  1. Changes in gut microbiota composition upon exercise

    Time frame: At baseline, after 7 weeks, after 13 weeks

    alfa-diversity, beta-diversity

  2. 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.

  3. 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

Secondary outcomes

  1. Changes in resting energy expenditure

    Time frame: Before and after exercise

    Indirect calorimetry

  2. Changes in continous cardiovascular monitoring

    Time frame: Before and after exercise

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2017
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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