Type 2 Diabetes and the Effect of Probiotics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Royal Veterinary and Agricultural University, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00413348
First received: December 18, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  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

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

Ages Eligible for Study:   25 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

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 April 15, 2014