- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01369979
Hepatic Sugar Metabolism Measured by PET/CT in Patients and Healthy Subjects
Hepatic Glucose Metabolism Measured by FDG PET/CT in Patients With Liver Disease and Healthy Subjects
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.
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Aarhus C, Denmark, 8000
- Aarhus University Hospital, PET-centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with chronic liver disease
Inclusion criteria
Exclusion Criteria
|
Liver vein catheter is placed in the heptic vein via the femoral vein, using fluoroscpoy as guidance.
Other Names:
|
Healthy subjects
Inclusion criteria
Exclusion Criteria
|
Liver vein catheter is placed in the heptic vein via the femoral vein, using fluoroscpoy as guidance.
Other Names:
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Sørensen, MD PhD, Aarhus University Hospital, PET-centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20100284
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Cirrhosis
-
Postgraduate Institute of Medical Education and...Society for the Study of Liver Diseases, Chandigarh ( India )UnknownDecompensated Cirrhosis of LiverIndia
-
SUUMC Central Military Hospital Dr Carol DavilaRecruiting
-
The Cleveland ClinicRecruiting
-
The Cleveland ClinicRecruitingCirrhosis, LiverUnited States
-
University of PittsburghNational Institute on Drug Abuse (NIDA)CompletedCirrhosis, LiverUnited States
-
Beth Israel Deaconess Medical CenterAmerican Association for the Study of Liver Diseases FoundationCompleted
-
Asian Institute of Gastroenterology, IndiaCompletedCirrhosis, LiverIndia
-
Sherief Abd-ElsalamUnknown
-
Fundació Institut de Recerca de l'Hospital de la...Spanish Clinical Research Network - SCReNWithdrawn
Clinical Trials on Liver vein catheter
-
Rutgers, The State University of New JerseyTerminatedLiver Disease | Brain DeathUnited States
-
Fudan UniversityNot yet recruitingLiver Metastases | Colorectal CarcinomaChina
-
Rigshospitalet, DenmarkMedtronic; Abbott Medical Devices; Biosense Webster, Inc.; Guidant CorporationCompletedAtrial Fibrillation | ArrhythmiaDenmark
-
Ankara UniversityCompletedComplication Rate | Number of TrialsTurkey
-
Asian Institute of Gastroenterology, IndiaCompletedNAFLD | Alcoholic HepatitisIndia
-
Universitätsklinikum Hamburg-EppendorfCompletedParoxysmal Atrial Fibrillation | Catheter Ablation StrategiesGermany
-
Vivek ReddyCompletedAtrial Fibrillation
-
St. Luke's-Roosevelt Hospital CenterWithdrawnAtrial Fibrillation | Arrhythmia | Congestive Heart FailureUnited States
-
University of PennsylvaniaCompletedAtrial FibrillationUnited States
-
Haukeland University HospitalUniversity Hospital of North Norway; St. Olavs HospitalCompletedPersistent Atrial FibrillationNorway