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| Sponsors and Collaborators: |
Rigshospitalet, Denmark Royal Veterinary and Agricultural University, Denmark |
|---|---|
| Information provided by: | Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT00413348 |
Purpose
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 | Intervention |
|---|---|
|
Type 2 Diabetes Healthy Endotoxemia |
Drug: Lactobacillus acidophilus NCFM |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Probiotics on Systemic Inflammation and Insulin Resistance in Type 2 Diabetics and Healthy Controls |
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | December 2007 |
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.
Eligibility| Ages Eligible for Study: | 25 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Anne Sofie Andreasen, MD | +45 3545 1616 | sofie_andreasen@msn.com |
| Contact: Bente K Pedersen, Preofessor | +45 3545 7797 | bkp@rh.dk |
| Denmark | |
| 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 |
More Information
| Study ID Numbers: | probiotics.sa.cim.rh.dk |
| Study First Received: | December 18, 2006 |
| Last Updated: | December 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00413348 History of Changes |
| Health Authority: | Denmark: National Board of Health |
|
Type 2 diabetes Probiotics Insulin-resistance |
Inflammation Hyperinsulinemic euglycemic clamp Endotoxin |
|
Systemic Inflammatory Response Syndrome Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Bacteremia Healthy Insulin Toxemia Inflammation |
Hyperinsulinism Sepsis Diabetes Mellitus, Type 2 Endotoxemia Endocrinopathy Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder |
|
Systemic Inflammatory Response Syndrome Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Bacteremia Infection Toxemia Inflammation |
Hyperinsulinism Sepsis Pathologic Processes Diabetes Mellitus, Type 2 Endotoxemia Insulin Resistance Glucose Metabolism Disorders |
