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HSPGs in leverbiopten in mensen met of zonder suikerziekte.


- candidate number8738
- NTR NumberNTR2641
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-dec-2010
- Secondary IDs09/205 METC AMC
- Public TitleHSPGs in leverbiopten in mensen met of zonder suikerziekte.
- Scientific TitleHSPG expression in non alcoholic steat hepatitis and type II Diabetes Mellitus.
- ACRONYMHASTRO
- hypothesisHepatic HSPG expression is altered in DM2 patients with NASH compared to controls and determines level of insulin resistance.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Dyslipemia, Non alcoholic steato hepatitis (NASH)
- Inclusion criteriaPatients with DM:
1. Caucasian males or females;
2. Age 18 - 60 years old;
3. Type 2 diabetes mellitus;
4. Presence of ultrasound confirmed NASH;
5. Undergoing gastric bypass surgery.

Controls:
1. Caucasian males or females;
2. Age 18 - 60 years old;
3. FHBL patients with NASH and Hepatitis C patients and Heamochromatosis patients undergoing a liverbiopsy for clinical staging of the disease and patients undergoing hemihepatectomy.
- Exclusion criteria1. Use of lipid lowering therapy (Modalim), hormone therapy or other medication which influences the lipid metabolism during the past 6 weeks;
2. Active malignancy (not applicable to hemihepatectomy patients);
3. Cholestasis.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-jan-2011
- planned closingdate15-dec-2011
- Target number of participants8
- Interventions1. Liverbiopsy;
2. Bloodwithdrawal.
- Primary outcomeHSPGs expression in liver tissue, measured by qPCR and western blot, in insulin resistant NASH versus non-insulin resistant NASH and controls.
- Secondary outcome1. Association between hepatic HSPGs expression en triglyceride-rich lipoproteins in non-fasting lipid samples;
2. Association between hepatic HSPGs expression and HOMA index.
- TimepointsAt the day of liverbiopsy, a fasting and non fasting blood sample will be withdrawn.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES H.C. Hassing
- CONTACT for SCIENTIFIC QUERIESDr. Stroes
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryRationale:
Non-alcoholic steato hepatitis (NASH) is one of the most common causes of chronic liver injury in many countries. Currently there is no therapeutic intervention to reduce or cure NASH.
NASH is frequently seen in patients with type 2 diabetes mellitus (DM2) and is associated with insulin resistance. However, patients with familial hypobeta lipoproteinaemia (FHBL) are also characterized by NASH yet were recently characterized NOT to have insulin resistance. Thus, different genetic factors driving different pathophysiological mechanisms are likely to be important for the development of NASH. Animal studies have indicated a role for heparan sulphate proteoglycans (HSPG) in the development of NASH associated dyslipidemia and insulin resistance. We would therefore like to investigate whether changes in expression of HSPG synthesizing and degrading enzymes are associated with presence of dyslipidemia and insulin resistance in NASH.

Primary Objective:
HSPG expression in liver tissue of patients with type 2 diabetes mellitus and NASH compared to liver tissue from subjects without type 2 diabetes mellitus with and without NASH.
Second Objective:
Correlation between HSPG expression in liver tissue with levels of triglyceride rich lipoproteins in non-fasting blood samples.
Third objective:
Correlation between HSPG expression in liver tissue and insulin resistance.

Study design:
Case control study.

Study population:
Caucasian males, aged between 18 and 60 years of age, with type 2 diabetes mellitus, undergoing gastric bypass surgery.
Controls: FHBL patients with NASH and Hepatitis C patients and Heamochromatosis patients undergoing a liverbiopsy for clinical staging of the disease. And patients undergoing hemihepatectomy.

Intervention:
During a clinically scheduled gastric bypass surgery, hemihepatectomy or liver biopsy, liver tissue will be collected and blood will be withdrawn.

Main study parameters/endpoints:
1. HSPGs expression in liver tissue, measured by qPCR and western blot, in insulin resistant NASH versus non-insulin resistance with and without NASH;
2. Association between hepatic HSPGs expression and triglyceride-rich lipoproteins in non fasting lipid samples;
3. Association between hepatic HSPGs expression and HOMA index.
- Main changes (audit trail)
- RECORD6-dec-2010 - 27-dec-2010


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