Type 2 Diabetes and the Effect of Probiotics
|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||Phase|
|Type 2 Diabetes Healthy Endotoxemia||Drug: Lactobacillus acidophilus NCFM||Not Applicable|
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)|
|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|
|Study Completion Date :||December 2007|
- Change in insulin-resistance
- Change in inflammatory response to E. coli endotoxin injection
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413348
|Contact: Anne Sofie Andreasen, MD||+45 3545 firstname.lastname@example.org|
|Contact: Bente K Pedersen, Preofessor||+45 3545 email@example.com|
|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|