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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

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

NCT ID

NCT00413348

First Posted

December 18, 2006

Last Updated

December 18, 2006

Sponsor

Rigshospitalet, Denmark

Collaborators

Royal Veterinary and Agricultural University, Denmark

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

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

sofie_andreasen@msn.com

First Name & Middle Initial & Last Name or Official Title & Degree

Bente K Pedersen, Preofessor

Phone

+45 3545 7797

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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