Insulin resistance
Conditions
Interventions
Telmisartan versus standard therapy against hypertension
Comparison of two treatment arms:
1. Intervention arm: Telmisartan 40 or 80 mg daily, oral use - dependent on compliance of patients
2. Contro
Sponsors
Klinikum Chemnitz gGmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adult patients aged 18 - 70 years inclusive, legally competent 2. Written informed consent 3. Presence of arterial hypertension 4. Evidence of increased Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) >2 5. Evidence of decreased Insulin Sensitivity Index (ISI-Matsuda) <4 6. Presence of increased liver enzymes 6.1. Alanine transaminase (ALT) 6.2. Gamma-glytamyl transpeptidase (gamma-GT) 7. Presence of fatty liver indicated by sonography 8. Ethnic background: caucasian 9. Presence of negative pregnancy test
Exclusion criteria
Exclusion criteria: 1. Other liver diseases: e.g. virus-induced hepatitis, hemochromatosis 2. Presence of severe increased liver enzymes as an evidence for serious liver diseases 2.1. ALT > 4 µkat/l 2.2. Aspartate Aminotransferase (AST) > 4 µkat/l 2.3. Gamma-GT > 10 µkat/l 3. Increased AST enzyme activity in comparison to ALT enzyme activity as an evidence for an alcoholic fatty liver disease (AFLD) 4. Obstructive disease of bile ducts and cholestasis 5. Pre-treatment of hypertension with sartans 6. Chronic infections with increased C-Reactive Protein (CRP) serum concentration 7. Hypersensitivity to telmisartan or another ingredient of medicinal product 8. Hereditary fructose intolerance based on sorbitol in medicinal product 9. Presence of an angioneurotic oedema during former treatment with ACE-inhibitors or angiotensin-II-receptor-antagonists 10. Presence of manifest diabetes mellitus type 2 11. Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days 12. Pregnancy, lactation period or female patients seeking to become pregnant during interventional period 13. Low compliance or inability to understand instructions/study documents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of insulin resistance reflected by normalised or increased ISI-Matsuda (> 4) 6 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement of insulin resistance reflected by normalised or increased ISI-Matsuda (> 4) 2. Improvement of insulin resistance reflected by normalised or decreased HOMA-IR (< 2) 3. Improvement of hypertension measured by blood pressure over 24 h 4. Improvement / normalisation of the liver enzymes (gamma-GT, ALT) measured by their serum concentrations 5. Improvement / normalisation of tissue structure of liver analyzed by sonography 6. Improvement / normalisation of the blood lipids measured by serum concentrations of triglycerids, total cholesterol, high density lipoprotein (HDL) and low density lipoprotein (LDL) 7. Improvement / normalisation of tissue structure of liver analysed by sonographyferric marker measured by serum concentrations of ferritin, iron and transferrin 8. Improvement / normalisation of Body mass index and abdominal girth 9. Improvement / normalisation of uric acid measured by the serum concentration All secondary outcomes will be measured at 3 and 6 months after treatment with Telmisartan | — |
Countries
Germany
Outcome results
None listed