Influence of Telmisartan on insulin resistance, hypertension, non-alcoholic fatty liver MedDRA version: 12.0 Level: LLT Classification code 10020772 Term: Hypertension MedDRA version: 12.0 Level: LLT Classification code 10052066 Term: Metabolic syndrome MedDRA version: 12.0 Level: LLT Classification code 10022489 Term: Insulin resistance MedDRA version: 12.0 Level: LLT Classification code 10016261 Term: Fatty liver
Conditions
Interventions
Trade Name: Kinzalmono 80 mg
Product Name: Kinzalmono 80 mg
Product Code: BAY68-9291
Pharmaceutical Form: Tablet
INN or Proposed INN: TELMISARTAN
CAS Number: 144701-48-4
Concentration unit: mg milligr
Sponsors
Klinik für Innere Medizin II der Klinikum Chemnitz gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of insulin resistance reflected by normalized or increased ISI-Matsuda (> 4) 6 months after treatment with Telmisartan;Secondary Objective: Improvement of insulin resistance reflected by normalized or increased ISI-Matsuda (> 4) 3 months after treatment with Telmisartan Improvement of insulin resistance reflected by normalized or decreased HOMA-IR (< 2) 3 and 6 months after treatment with Telmisartan Improvement of hypertension measured by blood pressure over 24 h Improvement / normalization of the liver enzymes (gamma-GT, ALT) measured by their serum concentrations Improvement / normalization of tissue structure of liver analyzed by sonography Improvement / normalization of the blood lipids measured by serum concentrations of triglycerids, total cholesterol, HDL and LDL Improvement / normalization of tissue structure of liver analyzed by sonographyferric marker measured by serum concentrations of ferritin, iron and transferrin Improvement / normalization of Body mass index and abdominal girth Improvement / normalization of uric acid measured by the serum concentration;Primary end point(s): Normalization / Increasing of ISI-Matsuda | — |
Countries
Germany
Outcome results
None listed