Type 2 Diabetes and the Effect of Probiotics
Recruitment status was Recruiting
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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Effect of Probiotics on Systemic Inflammation and Insulin Resistance in Type 2 Diabetics and Healthy Controls |
- Change in insulin-resistance
- Change in inflammatory response to E. coli endotoxin injection
| 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:
- Healthy
- Type 2 diabetes
Exclusion Criteria:
- Heart failure
- Lung disease
- Infections in the last two weeks before endotoxin injections.
- Treatment with antibiotics
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00413348 History of Changes |
| Other Study ID Numbers: | probiotics.sa.cim.rh.dk |
| Study First Received: | December 18, 2006 |
| Last Updated: | December 18, 2006 |
| Health Authority: | Denmark: National Board of Health |
Keywords provided by Rigshospitalet, Denmark:
|
Type 2 diabetes Probiotics Insulin-resistance |
Inflammation Hyperinsulinemic euglycemic clamp Endotoxin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Inflammation Insulin Resistance Endotoxemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pathologic Processes Hyperinsulinism Bacteremia Sepsis Infection Toxemia Systemic Inflammatory Response Syndrome |
ClinicalTrials.gov processed this record on June 17, 2013