NCT00413348

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 19, 2006

Status Verified

December 1, 2006

First QC Date

December 18, 2006

Last Update Submit

December 18, 2006

Conditions

Type 2 DiabetesHealthyEndotoxemia

Keywords

Type 2 diabetesProbioticsInsulin-resistanceInflammationHyperinsulinemic euglycemic clampEndotoxin

Outcome Measures

Primary Outcomes (2)

  • Change in insulin-resistance

  • Change in inflammatory response to E. coli endotoxin injection

Interventions

Lactobacillus acidophilus NCFMDRUG

Eligibility Criteria

Age25 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Type 2 diabetes

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Inflammation and metabolism 7641 and Intensive Care Unit 4131, Rigshospitalet

Copenhagen, DK-2100, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2EndotoxemiaInsulin ResistanceInflammation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromePathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinism

Study Officials

  • Anne Sofie Andreasen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Sofie Andreasen, MD

CONTACT

+45 3545 1616sofie_andreasen@msn.com

Bente K Pedersen, Preofessor

CONTACT

+45 3545 7797bkp@rh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2006

First Posted

December 19, 2006

Study Start

November 1, 2006

Study Completion

December 1, 2007

Last Updated

December 19, 2006

Record last verified: 2006-12

Locations

DK(1)