Hepatic Sugar Metabolism Measured by PET/CT in Patients and Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01369979
First received: June 8, 2011
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

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.

Condition Intervention
Liver Cirrhosis
Procedure: Liver vein catheter

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Hepatic Glucose Metabolism Measured by FDG PET/CT in Patients With Liver Disease and Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Biospecimen Retention:   Samples Without DNA

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


Enrollment: 13
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Liver vein catheter is placed in the heptic vein via the femoral vein, using fluoroscpoy as guidance.
Other Name: Cook, Torcon NB Advantage 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
Liver vein catheter is placed in the heptic vein via the femoral vein, using fluoroscpoy as guidance.
Other Name: Cook, Torcon NB Advantage Catheter

Detailed Description:

The LC for FDG is determined in 8 patients with liver disease and 8 healthy volunteers with and without glucose-clamp on two different days at 3-5 week intervals. The individual order of the two examinations will be randomized. The subjects fast overnight before the examination but are allowed to drink water and take usual medication.

When arriving at the PET centre, venflons are placed in a cubital vein in both arms and an ICG infusion is started in one of them. On the day with the glucose-clamp, an infusion of insulin and glucose is started in the second venflon. Next, an artflon is placed in one radial artery and a lever vein catheteter is placed via an introducer catheter in the left femoral vein under sterile conditions and local anesthetic (Lidocaine). The position of the liver vein catheter is checked with fluoroscopy.

On each experimental day, a bolus of 200 MBq FDG + 25 μCi [3H] glucose (diluted with saline up to 10 ml) is given intravenously at the start of a 60-min PET scan of the liver. Blood samples from a peripheral artery and a liver vein are collected for determination of blood concentrations of FDG and [3H]glucose at appropriate intervals.

In the experiment with glucose-clamp, an intravenous infusion of insulin (0.6 mU/kg/min) is given and blood glucose is measured every 10 min and kept constant at around 5 mM by infusing 20% glucose (infusion rate adjusted according to blood glucose).

During each study, the hepatic blood flow rate is measured by giving an intravenous infusion of indocyanine green (ICG) and collecting arterial and liver vein blood samples (Fick's principle).

Blood samples are analyzed for concentrations of FDG (gammacounter), [3H]glucose (liquid-scintillation counter), glucose (enzymatic assay) and ICG (spectrophotometric).

When the experiment is finished, all infusions are terminated and the liver vein catheter is removed and hemostasis ensured by manual compression (10 minutes) and bed rest for 30 minutes before the subject is allowed to stand. The artflon is then removed and hemostasis ensured by manual compression (10 minutes). Finally, the venflons are removed.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

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 underwent surgery for obesity
  • Pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01369979

Locations
Denmark
Aarhus University Hospital, PET-centre
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Michael Sørensen, MD PhD Aarhus University Hospital, PET-centre
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01369979     History of Changes
Other Study ID Numbers: 20100284
Study First Received: June 8, 2011
Last Updated: June 25, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Lumped constant
FDG
PET

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014