Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00412906
First received: December 18, 2006
Last updated: May 20, 2008
Last verified: May 2008
  Purpose

The aim of the present protocol is to study gene activity in fat and muscle tissue in type 2 diabetics and healthy volunteers after injection of E. coli endotoxin.We hereby hope to gain insight in some mechanisms behind the association between inflammation and insulin resistance.


Condition Intervention
Healthy
Type 2 Diabetes
Endotoxemia
Drug: Escherichia Coli Endotoxin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Gene Expression in Fat and Muscle Tissue in Type 2 Diabetics and Healthy Controls During Experimental Endotoxemia

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Gene expression evaluated by measuring mRNA via RT-PCR. Plasma cytokine content, PLasma PAI-1 content, endotoxemia score

Secondary Outcome Measures:
  • Mean Arterial Pressure, heart rate, Temperature,

Estimated Enrollment: 48
Study Start Date: November 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Numerous studies have shown an association between low-grade inflammation and insulin-resistance in type 2 diabetics. It is also well-known that septic patients often develop insulin-resistance. The pathogenetic mechanisms behind the association between inflammation and insulin-resistance is not fully understood.

In this study we create an experimental inflammation by giving E. coli endotoxin 0,3 ng/kg iv to type 2 diabetics and healthy controls. Muscle biopsies are taken at 0, 2, 4 and 6 hours after injection, while fat biopsies are taken 0, 2, 4, 6 and 8 hours after endotoxin. mRNA for adiponectin, leptin, PPAR-gamma, PGC-1, PAI-1 and cytokines in tissue is later measured by RT-PCR.

Blood samples are drawn on an hourly basis until 8 hours after endotoxin injection for common biochemical analyses including white blood cell count. Plasma is spared and later analyzed for cytokines, PAI-1 and VCAM-1/ICAM-1.

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Type 2 diabetes

Exclusion Criteria:

  • Heart failure
  • Lung disease
  • Anti-coagulation treatment
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00412906

Locations
Denmark
Centre of Inflammaiton and Metabolism, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Anne Sofie Andreasen, MD Rogshospitalet, Denmark
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre of Inflammation and Metabolism, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00412906     History of Changes
Other Study ID Numbers: DM2.sa.cim.rh.dk
Study First Received: December 18, 2006
Last Updated: May 20, 2008
Health Authority: Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:
Low-grade inflammation
insulin resistance
Metabolism
Type 2 diabetes
Endotoxemia
Fat tissue
Muscle tissue
RT-PCR

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endotoxemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 10, 2014