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NCT Number: NCT00412906

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

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.

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Key information

Conditions

Healthy Bacteremia Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Endotoxemia Glucose Metabolism Disorders Hyperinsulinism Infections Inflammation Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia Type 2 Diabetes

Age range

25 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Inflammaiton and Metabolism, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • Type 2 diabetes

Exclusion criteria

  • Heart failure
  • Lung disease
  • Anti-coagulation treatment

Treatment and study plan

Escherichia coli Endotoxin

Drug

Primary outcomes

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

Secondary outcomes

  1. Mean Arterial Pressure, heart rate, Temperature,

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Study of Gene Expression in Fat and Muscle Tissue in Type 2 Diabetics and Healthy Controls During Experimental Endotoxemia

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 19, 2006
Registry last updated
May 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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