NCT00929136

Brief Summary

The aim of the study is to isolate the direct effects of endotoxin on glucose, lipid and protein metabolism. Eight healthy volunteers are enrolled. The hypothesis is that endotoxin will induce insulin resistance, lypolysis and proteolysis acutely.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 4, 2010

Status Verified

October 1, 2010

Enrollment Period

11 months

First QC Date

June 22, 2009

Last Update Submit

October 1, 2010

Conditions

Healthy

Keywords

EndotoxinInsulin resistanceLipolysisProteolysisIntracellular Insulin SignalingRegional effects of inflammation/endotoxin

Outcome Measures

Primary Outcomes (1)

  • glucose concentration

    360 minutes observation

Secondary Outcomes (3)

  • Regional arteriovenous amino-acid balance

    measured at t=180 and 360 minutes

  • Intra-cellular insulin signaling

    measured at t=0, 120, and, 210 minutes

  • Regional arteriovenous lipid balance

    measured at t=180 and 360 minutes

Study Arms (1)

Endotoxin

EXPERIMENTAL
Biological: USP endotoxin

Interventions

USP endotoxinBIOLOGICAL

Continuous intra-arterial infusion

Also known as: USP Endotoxin, LOT: G3E069
Endotoxin

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal health
  • \< BMI \< 28
  • Written Informed Concent

You may not qualify if:

  • Any disease
  • Any use of medication
  • Recent immobilization of a lower extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Medical Research Laboratories, Dept. M, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Buhl M, Bosnjak E, Vendelbo MH, Gjedsted J, Nielsen RR, K-Hafstrom T, Vestergaard ET, Jessen N, Tonnesen E, Moller AB, Pedersen SB, Pilegaard H, Bienso RS, Jorgensen JO, Moller N. Direct effects of locally administered lipopolysaccharide on glucose, lipid, and protein metabolism in the placebo-controlled, bilaterally infused human leg. J Clin Endocrinol Metab. 2013 May;98(5):2090-9. doi: 10.1210/jc.2012-3836. Epub 2013 Mar 29.

    PMID: 23543661DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mads Buhl, M.D.

    Medical Department M (Endocrinology and Diabetes), Århus University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • Niels Moller, M.D., professor, Dmsc

    Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 26, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 4, 2010

Record last verified: 2010-10

Locations

DK(1)