The Importance of the Gut Microbiota in Body Weight Control and Insulin Sensitivity

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Male

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. In addition, these studies have shown changes in gut permeability inducing a pro-inflammatory state, changes in adipose tissue function and inflammation, effects on energy harvesting and metabolism, skeletal muscle fatty acid partitioning and fat oxidation. Human data is lacking, although several studies suggested that the composition of the gut microbiota differs between lean and obese, and between diabetic and non-diabetic individuals.

OBJECTIVE: To provide insight in the physiological significance and underlying mechanisms involved in the relation between gut microbiota, energy balance and insulin sensitivity in overweight men with impaired glucose homeostasis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Collaborator: Top Institute Food and Nutrition
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Insulin; Vancomycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)