Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Type 2 Diabetes and the Effect of Probiotics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Royal Veterinary and Agricultural University, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00413348
First received: December 18, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted

December 18, 2006
December 18, 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.
 
Recruiting
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
Male
25 Years to 80 Years
Yes
Contact: Anne Sofie Andreasen, MD +45 3545 1616 sofie_andreasen@msn.com
Contact: Bente K Pedersen, Preofessor +45 3545 7797 bkp@rh.dk
Denmark
 
NCT00413348
probiotics.sa.cim.rh.dk
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