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

NCT03380338 | Completed

• 1 other identifier: Bootcamp2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Insulin Sensitivity/Resistance

Keywords

Gut microbiota

Outcome Measures

Primary Outcomes (3)

• Changes in gut microbiota composition upon exercise

  alfa-diversity, beta-diversity

  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.

  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

  Before and after exercise, i.e. from first visit (0 weeks) untill last visit (13 weeks)

Secondary Outcomes (2)

• Changes in resting energy expenditure

  Before and after exercise

• Changes in continous cardiovascular monitoring

  Before and after exercise

Study Arms (1)

Exercise program

EXPERIMENTAL

Twice weekly exercise program, combined aerobic and strenght training

Behavioral: Combined aerobic and strength exercise

Interventions

Combined aerobic and strength exercise BEHAVIORAL

Exercise program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 21, 2017
• Study Start: May 11, 2016
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)