Evaluation of the incidence of liver enzyme abnormalities and hepatic steatosis in all type 2 diabetes mellitus patients (about n=1500) treated at the outpatient clinic internal medicine of the St Lucas Andreas Hospital
ID
Source
Brief title
Condition
- Diabetic complications
- Gastrointestinal inflammatory conditions
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disturbed liver enzymes (i.e. AP, gammaGt, ASAT and ALAT)
Increased hepatic echogenicity (hepatic steatosis)
Secondary outcome
not applicable
Background summary
The consequence of an increasing prevalence of obesity and type 2 diabetes
mellitus (DM2) is an increase in patients with hepatic steatosis (HS). 80-90%
patients of DM2 suffers from HS of which 20% finally develops steatohepatitis
and eventually livercirrhosis. Little is known about the precise incidence.
Pathophysiologically, a two-hit theory is proposed. Insulin resistance leading
to hepatic lipid accumulation is the first hit. Subsequently oxidative stress
with formation of oxygen species and lipid peroxidation contributes to a second
hit. The AMC in collaboration with the VUMC developed an outpatient clinic for
patients suffering from NASH. Research aims are the development of non-invasive
diagnostic procedures and in the (near) future therapeutic interventions.
Besides these aims, the exact incidence of NASH and DM2 is relevant. Early
detection of HS and the resulting medical intervention will lead to an
improvement of the metabolic syndrome.
Study objective
Evaluation of the incidence of liver enzyme abnormalities and hepatic steatosis
in all type 2 diabetes mellitus patients (about n=1500) treated at the
outpatient clinic internal medicine of the St Lucas Andreas Hospital
Study design
A single venous blood sample (10 cc)is taken during standard blood sampling
(standard care). Liver enzymes will be measured (alanine
aminotransferases(ALAT), asparagin aminotransferases (ASAT),
gamma-glutamyl-transferases (*Gt), alkaline phosphatase (AP), bilirubin and
lactate dehydrogenase (LDH). Clinical data are collected, specifically diabetic
complications and other liver diseases.
If any liver enzyme abnormality then further analysis will be performed:
- repeat liver enzymes, if again abnormal then;
serology of viral hepatitis (HBsAg and anti-HCV)
auto-immune serology (ANA, anti-SMA)
abdominal ultrasound
sampling of one extra tube (10 cc): storage of plasma and buffy
coat
- when negative analysis and on ultrasound only hepatic steatosis patient will
be asked to participate in the outpatient clinic NASH at AMC or VUMC
Study burden and risks
Single venous blood sampling (10 cc)
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
All type 2 diabetes mellitus patients visiting the outpatient clinic internal medicine of the Sint Lucas Andreas Hospital Amsterdam
Exclusion criteria
none
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 | NL11695.029.06 |