Type 2 Diabetes and the Effect of Probiotics
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|ClinicalTrials.gov Identifier: NCT00413348|
Recruitment Status : Unknown
Verified December 2006 by Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : December 19, 2006
Last Update Posted : December 19, 2006
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.
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Healthy Endotoxemia||Drug: Lactobacillus acidophilus NCFM|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Probiotics on Systemic Inflammation and Insulin Resistance in Type 2 Diabetics and Healthy Controls|
|Study Start Date :||November 2006|
|Estimated Study Completion Date :||December 2007|
- Change in insulin-resistance
- Change in inflammatory response to E. coli endotoxin injection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413348
|Contact: Anne Sofie Andreasen, MD||+45 3545 email@example.com|
|Contact: Bente K Pedersen, Preofessor||+45 3545 firstname.lastname@example.org|
|Center of Inflammation and metabolism 7641 and Intensive Care Unit 4131, Rigshospitalet||Recruiting|
|Copenhagen, Denmark, DK-2100|
|Principal Investigator: Anne Sofie Andreasen, MD|
|Principal Investigator:||Anne Sofie Andreasen, MD||Rigshospitalet, Denmark|