Liver CirrhosisNCT01369979
Hepatic Sugar Metabolism Measured by PET/CT in Patients and Healthy Subjects
An observational study of Liver Cirrhosis, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Liver vein catheter
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruited via 2 newspapers: Århus Onsdag and Århus Stiftstidende, and so will be based in the area these newspapers are distributed in.
Who may be able to join
- Age between 40 and 70 years
- BMI between 20 and 26
Who cannot join
- Diabetes mellitus
- Glucose intolerance
- Medical treatment of portal hypertension
- People who have underwent surgery for obesity
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Cirrhosis
- Being tested
- Liver vein catheter
- Keywords
- Lumped constant, FDG, PET
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver vein catheterProcedure or surgery
Also called Cook, Torcon NB Advantage Catheter
Liver vein catheter is placed in the heptic vein via the femoral vein, using fluoroscpoy as guidance.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Liver vein catheter |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Sørensen, MD PhD, Principal investigator, Aarhus University Hospital, PET-centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369979
- Sponsor's protocol ID
- 20100284
- Status last verified
- Jun 2012
- First submitted
- 8 Jun 2011
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Glucose Metabolism Measured by FDG PET/CT in Patients With Liver Disease and Healthy Subjects
- ClinicalTrials.gov ID
- NCT01369979
- Acronym / sponsor ID
- 20100284
- Conditions
- Liver Cirrhosis
- Keywords
- Lumped constant, FDG, PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic liver disease | – | Procedure: Liver vein catheterInclusion 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 |
| Healthy subjects | – | Procedure: Liver vein catheterInclusion 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruited via 2 newspapers: Århus Onsdag and Århus Stiftstidende, and so will be based in the area these newspapers are distributed in.
Key inclusion criteria (2 listed)
- Age between 40 and 70 years
- BMI between 20 and 26
Key exclusion criteria (5 listed)
- Diabetes mellitus
- Glucose intolerance
- Medical treatment of portal hypertension
- People who have underwent surgery for obesity
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver vein catheterAlso: Cook, Torcon NB Advantage CatheterLiver vein catheter is placed in the heptic vein via the femoral vein, using fluoroscpoy as guidance. | Procedure or surgery | Healthy subjects, Patients with chronic liver disease |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sørensen, MD PhD principal investigator
Aarhus University Hospital, PET-centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.