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Type 2 Diabetes and the Effect of Probiotics

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413348
First Posted: December 19, 2006
Last Update Posted: December 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Royal Veterinary and Agricultural University, Denmark
Information provided by:
Rigshospitalet, Denmark
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effect of Probiotics on Systemic Inflammation and Insulin Resistance in Type 2 Diabetics and Healthy Controls

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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
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 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413348


Contacts
Contact: Anne Sofie Andreasen, MD +45 3545 1616 sofie_andreasen@msn.com
Contact: Bente K Pedersen, Preofessor +45 3545 7797 bkp@rh.dk

Locations
Denmark
Center of Inflammation and metabolism 7641 and Intensive Care Unit 4131, Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100
Principal Investigator: Anne Sofie Andreasen, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Royal Veterinary and Agricultural University, Denmark
Investigators
Principal Investigator: Anne Sofie Andreasen, MD Rigshospitalet, Denmark
  More Information

ClinicalTrials.gov Identifier: NCT00413348     History of Changes
Other Study ID Numbers: probiotics.sa.cim.rh.dk
First Submitted: December 18, 2006
First Posted: December 19, 2006
Last Update Posted: December 19, 2006
Last Verified: December 2006

Keywords provided by Rigshospitalet, Denmark:
Type 2 diabetes
Probiotics
Insulin-resistance
Inflammation
Hyperinsulinemic euglycemic clamp
Endotoxin

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Endotoxemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes