Viewing Study NCT00413348



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Study NCT ID: NCT00413348
Status: UNKNOWN
Last Update Posted: 2006-12-19
First Post: 2006-12-18

Brief Title: Type 2 Diabetes and the Effect of Probiotics
Sponsor: Rigshospitalet Denmark
Organization: Rigshospitalet Denmark

Study Overview

Official Title: Effect of Probiotics on Systemic Inflammation and Insulin Resistance in Type 2 Diabetics and Healthy Controls
Status: UNKNOWN
Status Verified Date: 2006-12
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed 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 N24 and healthy control N24 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 03 ngkg before and after the intervention Also the insulin-sensitivity is measured with an hyperinsulinemic euglycemic clamp before and after L acidophilus NCFM

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None