Type 2 Diabetes MellitusNCT03380338
The Effect of Exercise on Gut Microbiota in Type 2 Diabetic Patients
A study testing Combined aerobic and strength exercise in people with Type 2 Diabetes Mellitus and Insulin Sensitivity/Resistance, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Insulin Sensitivity/Resistance
- What is being tested?
- Combined aerobic and strength exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 May 2016to 29 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1081 HV
About this study
Official title: Lifestyle Intervention in Patients With Diabetes Type 2 and the Association With the Gut Microbiota
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.
Read the 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
- Being tested
- Combined aerobic and strength exercise
- Keywords
- Gut microbiota
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined aerobic and strength exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise program | Experimental | Twice weekly exercise program, combined aerobic and strenght training Receives: Behavioral: Combined aerobic and strength exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota composition upon exercise
alfa-diversity, beta-diversity
Measured: At baseline, after 7 weeks, after 13 weeks
Change in insulin senistivity
Rate of disappearance measured by the hyperinsulinemic-euglycemic clamp with stable glucose isotopes.
Measured: Before and after exercise, i.e. from first visit (0 weeks) untill last visit (13 weeks)
Change in capillary recruitment
Insulin-induced capillary recruitment in skeletal muscle and heart
Measured: Before and after exercise, i.e. from first visit (0 weeks) untill last visit (13 weeks)
Secondary outcomes (2)
Changes in resting energy expenditure
Indirect calorimetry
Measured: Before and after exercise
Changes in continous cardiovascular monitoring
Measured: Before and after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start11 May 2016
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Serne, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380338
- Sponsor's protocol ID
- Bootcamp2
- Status last verified
- May 2019
- First submitted
- 8 Dec 2017
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention in Patients With Diabetes Type 2 and the Association With the Gut Microbiota
- ClinicalTrials.gov ID
- NCT03380338
- Acronym / sponsor ID
- Bootcamp2
- Keywords
- Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 11 May 2016 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise program | Experimental | Behavioral: Combined aerobic and strength exerciseTwice weekly exercise program, combined aerobic and strenght training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined aerobic and strength exercise | Behavioural | Exercise program |
Primary outcome
Changes in gut microbiota composition upon exercise
Time frame: At baseline, after 7 weeks, after 13 weeks
alfa-diversity, beta-diversity
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
2 secondary outcomes
Changes in resting energy expenditure
Time frame: Before and after exercise
Changes in continous cardiovascular monitoring
Time frame: Before and after exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined aerobic and strength exercise in people with Type 2 Diabetes Mellitus and Insulin Sensitivity/Resistance, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota composition upon exercise (time frame: At baseline, after 7 weeks, after 13 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.