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Trial record 53 of 80602 for:    measured

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

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ClinicalTrials.gov Identifier: NCT01369979
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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
Liver Cirrhosis 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.


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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 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Group/Cohort 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 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




Biospecimen Retention:   Samples Without DNA
Plasma for measuring levels of ICG, insulin, c.peptide, FFA, glucagon,and 3H-glucose.


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369979


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

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01369979     History of Changes
Other Study ID Numbers: 20100284
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012
Keywords provided by University of Aarhus:
Lumped constant
FDG
PET
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics