Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 53 of 81427 for:    measured

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 8, 2011
First Posted Date June 9, 2011
Last Update Posted Date June 26, 2012
Study Start Date May 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01369979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hepatic Sugar Metabolism Measured by PET/CT in Patients and Healthy Subjects
Official Title Hepatic Glucose Metabolism Measured by FDG PET/CT in Patients With Liver Disease and Healthy Subjects
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.
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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma for measuring levels of ICG, insulin, c.peptide, FFA, glucagon,and 3H-glucose.
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.
Condition Liver Cirrhosis
Intervention 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
Study Groups/Cohorts
  • 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
    Intervention: 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
    Intervention: Procedure: Liver vein catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 25, 2012)
13
Original Estimated Enrollment
 (submitted: June 8, 2011)
16
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01369979
Other Study ID Numbers 20100284
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Aarhus
Study Sponsor University of Aarhus
Collaborators Not Provided
Investigators
Principal Investigator: Michael Sørensen, MD PhD Aarhus University Hospital, PET-centre
PRS Account University of Aarhus
Verification Date June 2012