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

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT01369979
Collaborator
(none)
13
Enrollment
1
Location
13
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Liver vein 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.

Study Design

Study Type:
Observational
Actual Enrollment :
13 participants
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
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Cook, Torcon NB Advantage Catheter

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      40 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of Aarhus
      ClinicalTrials.gov Identifier:
      NCT01369979
      Other Study ID Numbers:
      • 20100284
      First Posted:
      Jun 9, 2011
      Last Update Posted:
      Jun 26, 2012
      Last Verified:
      Jun 1, 2012
      Keywords provided by University of Aarhus
      Lumped constant
      FDG
      PET
      Additional relevant MeSH terms:
      Liver Cirrhosis
      Imidacloprid

      Study Results

      No Results Posted as of Jun 26, 2012