NCT01369979

Brief Summary

The investigators wish to determine the lumped constant (LC), which is a correction factor necessary for converting measurements of hepatic FDG metabolism (measured by PET) to those of regular glucose in patients with cirrhosis and healthy subjects. Working hypothesis

  • LC for FDG in liver tissue is not significantly different from unity in healthy subjects
  • LC for FDG in liver disease is significantly different from LC in healthy liver
  • Insulin changes the LC for FDG in liver tissue, but not by the same factor in liver disease and healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

1.1 years

First QC Date

June 8, 2011

Last Update Submit

June 25, 2012

Conditions

Keywords

Lumped constantFDGPET

Study Arms (2)

Patients with chronic liver disease

Inclusion criteria * Age between 40 and 70 years * BMI between 20 and 26 Exclusion Criteria * Diabetes mellitus * Glucose intolerance * Medical treatment of portal hypertension * People who have undergone surgery for obesity * Pregnancy

Procedure: Liver vein catheter

Healthy subjects

Inclusion criteria * Age between 40 and 70 years * BMI between 20 and 26 Exclusion Criteria * Diabetes mellitus * Glucose intolerance * Medical treatment of portal hypertension * People who have undergone surgery for obesity * Pregnancy

Procedure: Liver vein catheter

Interventions

Liver vein catheter is placed in the heptic vein via the femoral vein, using fluoroscpoy as guidance.

Also known as: Cook, Torcon NB Advantage Catheter
Healthy subjectsPatients with chronic liver disease

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recruited via 2 newspapers: Århus Onsdag and Århus Stiftstidende, and so will be based in the area these newspapers are distributed in.

You may qualify if:

  • Age between 40 and 70 years
  • BMI between 20 and 26

You may not qualify if:

  • Diabetes mellitus
  • Glucose intolerance
  • Medical treatment of portal hypertension
  • People who have underwent surgery for obesity
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, PET-centre

Aarhus C, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma for measuring levels of ICG, insulin, c.peptide, FFA, glucagon,and 3H-glucose.

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Cooking

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food HandlingFood IndustryIndustryTechnology, Industry, and Agriculture

Study Officials

  • Michael Sørensen, MD PhD

    Aarhus University Hospital, PET-centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 9, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations