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NCT00413348 Clinical Trial

Type 2 Diabetes and the Effect of Probiotics

Healthy Clinical Trial

Official title:
Effect of Probiotics on Systemic Inflammation and Insulin Resistance in Type 2 Diabetics and Healthy Controls

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00413348
Other study ID # probiotics.sa.cim.rh.dk
Secondary ID
Status Recruiting
Phase N/A
First received December 18, 2006
Last updated December 18, 2006
Start date November 2006
Est. completion date December 2007

Study information
Verified date December 2006
Source Rigshospitalet, Denmark
Contact Anne Sofie Andreasen, MD
Phone +45 3545 1616
Email sofie_andreasen@msn.com
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial 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.

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 (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.

Recruitment information / eligibility
Status Recruiting
Enrollment 48
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 80 Years
Eligibility Inclusion Criteria:

- Healthy

- Type 2 diabetes

Exclusion Criteria:

- Heart failure

- Lung disease

- Infections in the last two weeks before endotoxin injections.

- Treatment with antibiotics

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Lactobacillus acidophilus NCFM

Locations
Country Name City State
Denmark Center of Inflammation and metabolism 7641 and Intensive Care Unit 4131, Rigshospitalet Copenhagen

Sponsors (2)
Lead Sponsor Collaborator
Rigshospitalet, Denmark Royal Veterinary and Agricultural University, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in insulin-resistance
Primary Change in inflammatory response to E. coli endotoxin injection
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