NCT00413465

Brief Summary

The purpose of the present protocol is to study whether endotoxemia will affect the renal blood flow in type 2 diabetics and healthy volunteers.

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
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable healthy

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

HealthyType 2 DiabetesEndotoxemia

Keywords

Renal Plasma FlowEndotoxemiaType 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Renal plasma flow, Glomerular filtration rate, Plasma cytokine content, Endotoxemia score, Plasma angiotensin II and renin content, Plasma thromboxane B2 content, Plasma PAI-1 content

Secondary Outcomes (1)

  • Mean arterial pressure, Heart rate, Oxygen saturation, Body temperature,

Interventions

Escherichia Coli EndotoxinDRUG

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:

  • Renal failure
  • Heart failure
  • Lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensiv Care Unit, Rigshospitalet,

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Endotoxemia

Interventions

endotoxin, Escherichia coli

Condition Hierarchy (Ancestors)

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

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, Professor

CONTACT

+45 3545 7621bkp@rh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
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)