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Type 2 Diabetes and the Effect of Probiotics

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413348
First Posted: December 19, 2006
Last Update Posted: December 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Royal Veterinary and Agricultural University, Denmark
Information provided by:
Rigshospitalet, Denmark
December 18, 2006
December 19, 2006
December 19, 2006
November 2006
Not Provided
  • Change in insulin-resistance
  • Change in inflammatory response to E. coli endotoxin injection
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Type 2 Diabetes and the Effect of Probiotics
Effect of Probiotics on Systemic Inflammation and Insulin Resistance in Type 2 Diabetics and Healthy Controls

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Type 2 Diabetes
  • Healthy
  • Endotoxemia
Drug: Lactobacillus acidophilus NCFM
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
48
December 2007
Not Provided

Inclusion Criteria:

  • Healthy
  • Type 2 diabetes

Exclusion Criteria:

  • Heart failure
  • Lung disease
  • Infections in the last two weeks before endotoxin injections.
  • Treatment with antibiotics
Sexes Eligible for Study: Male
25 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00413348
probiotics.sa.cim.rh.dk
Not Provided
Not Provided
Not Provided
Not Provided
Rigshospitalet, Denmark
Royal Veterinary and Agricultural University, Denmark
Principal Investigator: Anne Sofie Andreasen, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP