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The effect of the knock down of gut microbiota by antibiotics on parameters of body weight control and insulin sensitivity

The effect of the knock down of gut microbiota by antibiotics on parameters of body weight control and insulin sensitivity - ANTIBIOTICS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39276
Enrollment
57
Registered
2012-02-29
Start date
2012-05-21
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adult-onset diabetes diabetes type 2 obesity overweight

Interventions

Subjects will be treated with vancomycin (500 mg 3 times per day), amoxicillin (500mg, 3 times per day) or placebo for 7 days.

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: BMI 25-35 kg/m2, insulin resistant (HOMA_IR > 2.2), caucasian, male, 35-70 years, impaired glucose tolerance (IGT: 2h plasma glucose during 75g OGTT 7.8-11.1 mmol/l) and/or impaired fasting glucose (plasma glucose >= 5.6), stable body weight for at least three months (±3 kg).

Exclusion criteria

Exclusion criteria: Known allergic reaction to vancomycin, teicoplanine, amoxicillin and other β-lactam antibiotics (penicillins and cefalosporins) or related antibiotics. Diabetes mellitus, hearing disorders, cardiovascular disease, kidney disease, cancer, asthma or bronchitis, liver malfunction, major illness with a life expectancy 3 hours per week. The use of the following drugs: β-blockers, lipid lowering-drugs (e.g. PPAR γ or PPARa (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, a-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin), anti-oxidants or chronic corticosteroids treatment (> 7 consecutive days of treatment).

Design outcomes

Primary

MeasureTime frame
Before and after treatment, insulin sensitivity (2 step hyperinsulinemic euglycemic clamp) will be investigated (hepatic and peripheral)

Secondary

MeasureTime frame
Secondary parameters are: fasting and postprandial energy expenditure and substrate metabolism (indirect calorimetry), in vivo fatty acid handling and fatty acid partitioning in skeletal muscle, and gut permeability (multi-sugar test). Furthermore, adipose tissue and skeletal muscle gene/protein expression of markers of oxidative capacity and inflammation will be determined (i.e. AMPK) in addition to inflammatory markers in plasma. Faecal and circulating short- chain fatty acids, and faecal gut microbiota composition (HITChip /NTG sequencing) will be assessed.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)