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Type 2 Diabetes and the Effect of Probiotics

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Rigshospitalet

Status

Unknown

Conditions

Healthy
Type 2 Diabetes
Endotoxemia

Treatments

Drug: Lactobacillus acidophilus NCFM

Study type

Interventional

Funder types

Other

Identifiers

NCT00413348
probiotics.sa.cim.rh.dk

Details and patient eligibility

About

Insulin-resistance in type 2 diabetes is associated with chronic inflammation. Anti-inflammatory actions might increase sensitivity to insulin. Since some probiotics have anti-inflammatory properties, ingestion of the probiotic bacteria Lactobacillus Acidophilus NCFM might increase insulin-sensitivity.

The inflammatory response to endotoxin injection and the insulin-sensitivity is examined before and after four weeks ingestion of probiotics.

Full description

Numerous studies have shown an association between insulin-resistance in type 2 diabetes and chronic low-grade inflammation. Some probiotics have an anti-inflammatory properties. Ingestion of probiotics might therefore, due to this property, increase sensitivity to insulin.

In this study type 2 diabetics (N=24) and healthy control (N=24) are given the probiotic bacteria Lactobacillus Acidophilus NCFM for four weeks. The anti-inflammatory effect is examined by evaluating the inflammatory response (White blood cell count, plasma-cytokines) to an iv injection of endotoxin (0,3 ng/kg) before and after the intervention. Also the insulin-sensitivity is measured with an hyperinsulinemic euglycemic clamp before and after L. acidophilus NCFM.

Sex

Male

Ages

25 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy
  • Type 2 diabetes

Exclusion criteria

  • Heart failure
  • Lung disease
  • Infections in the last two weeks before endotoxin injections.
  • Treatment with antibiotics

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Anne Sofie Andreasen, MD; Bente K Pedersen, Preofessor

Data sourced from clinicaltrials.gov

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