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Type 2 Diabetes and the Effect of Probiotics

Primary Purpose

Type 2 Diabetes, Healthy, Endotoxemia

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lactobacillus acidophilus NCFM
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Probiotics, Insulin-resistance, Inflammation, Hyperinsulinemic euglycemic clamp, Endotoxin

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy
  • Type 2 diabetes

Exclusion Criteria:

  • Heart failure
  • Lung disease
  • Infections in the last two weeks before endotoxin injections.
  • Treatment with antibiotics

Sites / Locations

  • Center of Inflammation and metabolism 7641 and Intensive Care Unit 4131, RigshospitaletRecruiting

Outcomes

Primary Outcome Measures

Change in insulin-resistance
Change in inflammatory response to E. coli endotoxin injection

Secondary Outcome Measures

Full Information

First Posted
December 18, 2006
Last Updated
December 18, 2006
Sponsor
Rigshospitalet, Denmark
Collaborators
Royal Veterinary and Agricultural University, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00413348
Brief Title
Type 2 Diabetes and the Effect of Probiotics
Official Title
Effect of Probiotics on Systemic Inflammation and Insulin Resistance in Type 2 Diabetics and Healthy Controls
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Royal Veterinary and Agricultural University, Denmark

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Healthy, Endotoxemia
Keywords
Type 2 diabetes, Probiotics, Insulin-resistance, Inflammation, Hyperinsulinemic euglycemic clamp, Endotoxin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lactobacillus acidophilus NCFM
Primary Outcome Measure Information:
Title
Change in insulin-resistance
Title
Change in inflammatory response to E. coli endotoxin injection

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Sofie Andreasen, MD
Phone
+45 3545 1616
Email
sofie_andreasen@msn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bente K Pedersen, Preofessor
Phone
+45 3545 7797
Email
bkp@rh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Sofie Andreasen, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Inflammation and metabolism 7641 and Intensive Care Unit 4131, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Sofie Andreasen, MD

12. IPD Sharing Statement

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Type 2 Diabetes and the Effect of Probiotics

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