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Sponsored by: |
Rigshospitalet, Denmark |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00413465 |
The purpose of the present protocol is to study whether endotoxemia will affect the renal blood flow in type 2 diabetics and healthy volunteers.
Condition | Intervention |
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Healthy Type 2 Diabetes Endotoxemia |
Drug: Escherichia Coli Endotoxin |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Renal Plasma Flow During Experimental Human Endotoxemia |
Estimated Enrollment: | 32 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | December 2007 |
Many septic patients develop acute renal failure and the risk is higher in patients with diabetes. The pathogenetic mechanisms behind the development of acute renal failure in connection with sepsis is not completely understood. One among many possible explanations is a change in renal hemodynamics. However, it is still largely unknown what happens to the renal plasma flow during human sepsis. In this study we give endotoxin injection (0,3 ng/kg) to type 2 diabetics and healthy controls as an experimental model of sepsis. Renal plasma flow and glomerular filtration rate are measured by DTPA-renography 1 day before before and 1,25 and 6,5 hours after injection of endotoxin. Furthermore WBC, plasma-cytokines,VCAM-1/ICAM-1, endothelin-1, Thromboxane B2, angiotensin 2, renin and PAI-1 are measured on an hourly basis up to 8 hours after endotoxin injection.
Ages Eligible for Study: | 25 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anne Sofie Andreasen, MD | +45 3545 1616 | sofie_andreasen@msn.com |
Contact: Bente K Pedersen, Professor | +45 3545 7621 | bkp@rh.dk |
Denmark | |
Intensiv Care Unit, Rigshospitalet, | Recruiting |
Copenhagen, Denmark, 2100 | |
Principal Investigator: Anne Sofie Andreasen, MD |
Principal Investigator: | Anne Sofie Andreasen, MD | Rigshospitalet, Denmark |
Study ID Numbers: | RPF.sa.cim.rh.dk |
Study First Received: | December 18, 2006 |
Last Updated: | December 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00413465 History of Changes |
Health Authority: | Denmark: National Board of Health |
Renal Plasma Flow Endotoxemia Type 2 diabetes |
Systemic Inflammatory Response Syndrome Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Bacteremia Healthy Toxemia |
Inflammation Sepsis Diabetes Mellitus, Type 2 Endotoxemia Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Systemic Inflammatory Response Syndrome Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Bacteremia Infection Toxemia |
Inflammation Sepsis Pathologic Processes Diabetes Mellitus, Type 2 Endotoxemia Glucose Metabolism Disorders |