EUCTR2009-015703-13-DEActive, not recruitingNot Applicable
The influence of Telmisartan on insulin resistance and fatty liver in patients suffer from hypertension - InReTel
Klinik für Innere Medizin II der Klinikum Chemnitz gGmbH0 sitesStarted: November 2, 2009Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- male or female adult patients aged 18 – 80 years inclusive, legally competent
- •- written informed consent
- •- presence of arterial hypertension
- •- evidence of increased HOMA-IR >2
- •- evidence of decreased ISI-Matsuda <4
- •- presence of increased liver enzymes (ALT and/or gamma-GT)
- •- presence of fatty liver indicated by sonography
- •- ethnic background: caucasian
- •- presence of negative pregnancy test
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- other liver diseases: e.g. virus-induced hepatitis, hemochromatosis
- •- presence of servere increased liver enzymes (ALT > 4 µkat/l; AST > 4 µkat/l and gamma-GT > 10 µkat/l) as an evidence for serious liver diseases
- •- increased AST enzym activity in comparison to ALT enzym activity as an evidence for an alcoholic fatty liver disease (AFLD)
- •- obstructive disease of bile ducts and cholestasis
- •- pretreatment of hypertension with sartans
- •- chronic infections resp. presence of increased CRP serum concentration
- •- hypersensitivity to telmisartan or another ingredient of medicinal product
- •- hereditary fructose intolerance based on sorbitol in medicinal product
- •- presence of an angioneurotic edema during former treatment with ACE-inhibitors or angiotensin-II-receptor-antagonists
- •- presence of manifest diabetes mellitus type 2
- •- concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days
- •- Pregnancy, lactation period or female patients seeking to become pregnant during interventional period
- •- Low compliance or inability to understand instructions/study documents
Investigators
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