Status:
COMPLETED
The Importance of the Gut Microbiota in Body Weight Control and Insulin Sensitivity
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Top Institute Food and Nutrition
Conditions:
Obesity
Insulin Resistance
Eligibility:
MALE
35-70 years
Phase:
NA
Brief Summary
BACKGROUND: The relation between gut microbiota and obesity originates from animal studies, showing that the change of gut microbiota can induce changes in both insulin resistance and body composition...
Detailed Description
The view on the putative significance of gut microbiota in metabolism emerged from animal studies. Bäcked et al. showed that germ free mice had 40% less body fat compared to conventionally raised mice...
Eligibility Criteria
Inclusion
- male
- 35-70 years
- caucasian
- overweight/obese (BMI 25-35 kg/m2)
- insulin resistant (Homeostasis Model of Assessment - Insulin Resistance (HOMA\_IR) \> 2.2)
- impaired glucose tolerance (IGT: 2h plasma glucose during 75g Oral Glucose Tolerance Test(OGTT) 7.8-11.1 mmol/l) and/or impaired fasting glucose (plasma glucose ≥ 5.6 mmol/l)
- body weight stable for at least three months (±3 kg)
Exclusion
- known allergic reaction to vancomycin, teicoplanin, amoxicillin and other β-lactam antibiotics (penicillins and cefalosporins) or related antibiotics
- diabetes mellitus
- hearing disorders
- cardiovascular disease
- kidney disease
- gastrointestinal disease
- cancer
- asthma or bronchitis
- liver malfunction
- major illness with a life expectancy \< 5 years
- diseases affecting glucose tolerance (e.g. pheochromocytoma, Cushing's syndrome, acromegaly), - - use of antibiotics in the past 3 months
- plans to lose weight and participation in organized sports activities for \>3 hours per week
- The use of β-blockers, lipid lowering-drugs, glucose-lowering agents (including all sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin), anti-oxidants or chronic corticosteroids treatment (\> 7 consecutive days of treatment)
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT02241421
Start Date
April 1 2012
End Date
November 1 2014
Last Update
September 10 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maastricht University
Maastricht, Netherlands