- Is there a correlation between liver fat content and inflammation in patients with or without STNFR-2 polymorphisms (-1031C, -863A)?- What is the correlation between weight reduction and decrease of hepatic steatosis?- What is the correlation…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of hepatic steatosis with 3.0 Tesla MR Spectroscopy in severely
obese patients before and after weight reduction established by bariatric
surgery and its correlation with clinical parameters and blood tests
Secondary outcome
Assessment of hepatic steatosis with 3.0 Tesla MR Spectroscopy in severely
obese patients before and after weight reduction established by bariatric
surgery and its correlation with clinical parameters and blood tests
Background summary
Hepatic steatosis is a benign condition characterized by an accumulation of
lipids in the liver. It is related to a range of etiological features such as
obesity, diabetes and dyslipidemia (the metabolic syndrome). Steatosis can
progress into a more serious variant, NASH (Non Alcoholic Steato Hepatitis).
This condition is associated with an inflammatory component, and in
approximately 20 percent of the patients it will ultimately result in liver
cirrhosis. Non-alcoholic fatty liver disease (NAFLD) is the term for the
spectrum of steatosis, NASH and cirrhosis, and is now recognized as the most
common chronic liver disease in the western world, affecting approximately 30 %
of the western population. These numbers are thought to increase even further
due to the obesity epidemic. Liver biopsy and histological examination has been
the reference standard for assessing hepatic steatosis but sampling errors are
considerable because of inhomogeneous distribution of fat in the liver.
However, imaging techniques (abdominal ultrasound and computed tomography) are
also prone to error and lack sensitivity and specificity. Proton Magnetic
Resonance Spectroscopy (1H-MRS) is a safe, non-invasive and reproducible
diagnostic tool that allows the semi-quantification of various components of
fat in the liver
Study objective
- Is there a correlation between liver fat content and inflammation in patients
with or without STNFR-2
polymorphisms (-1031C, -863A)?
- What is the correlation between weight reduction and decrease of hepatic
steatosis?
- What is the correlation between a reduction of steatosis and improvement of
insulin sensitivity?
- Does a decrease in hepatic steatosis relate to a decrease of inflammation in
individuals with positive
inflammation parameters?
Study design
In this prospective pilot study consenting consecutive patients with severe
overweight will undergo bariatric surgery. After informed consent we intend to
perform MR Spectroscopy of the liver before surgery and 4 months after surgery,
as well as assessment of clinical parameters and blood tests. 1H*MRS will be
performed by the department of Radiology, assessment of clinical parameters and
blood tests will be performed by the department of Hepatology/ AMC liver
center. Because the sensitivity and specificity of 3.0 Tesla 1H*MRS for the
measurement of hepatic steatosis is unknown, we were not able to calculate by
power analysis the number of subject required for the study. Therefore we
intend to include 30 patients. A lower number of individuals can be expected to
lead to insufficient numbers to study the study objectives
Study burden and risks
The patients in this study will undergo bariatric surgery (standard treatment),
two 1H-MRS scans and two clinical assessments and blood sampling. 1H-MRS is a
non-invasive, non-ionizing 45 minute examination in the MRI scanner, which
requires two extra visits to the hospital. The patient has to lie still on his
back in a MRI scanner for about 45 minutes. There is not a direct advantage for
the patient, except for extra insight in their disease. Patients are not
delayed in treatment for their disease. There will be little extra physical and
psychological discomfort associated with participation.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients over 18 years of age
Patients who will undergo bariatric surgery for weight reduction at the Rijnstate hospital in Arnhem
Exclusion criteria
Patients with extreme obesity (maximum weight limit MRI scanner 150kg, diameter 60 cm)
Patients under 18 years of age
Patients who are pregnant
Patients who are claustrophobic
Patients who have magnetic or radiofrequency sensitive implants
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL19636.018.07 |