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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Type 2 Diabetes Endotoxemia

Keywords

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Low-grade inflammation insulin resistance Metabolism Type 2 diabetes Endotoxemia Fat tissue Muscle tissue RT-PCR

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Escherichia Coli Endotoxin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Type 2 diabetes

Exclusion Criteria

* Heart failure
* Lung disease
* Anti-coagulation treatment

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Rigshospitalet

Principal Investigators

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Anne Sofie Andreasen, MD

Role: PRINCIPAL_INVESTIGATOR

Rogshospitalet, Denmark

Locations

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Centre of Inflammaiton and Metabolism, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Andreasen AS, Kelly M, Berg RM, Moller K, Pedersen BK. Type 2 diabetes is associated with altered NF-kappaB DNA binding activity, JNK phosphorylation, and AMPK phosphorylation in skeletal muscle after LPS. PLoS One. 2011;6(9):e23999. doi: 10.1371/journal.pone.0023999. Epub 2011 Sep 13.

Reference Type DERIVED

PMID: 21931634 (View on PubMed)

Other Identifiers

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DM2.sa.cim.rh.dk

Identifier Type: -

Identifier Source: org_study_id