The influence of Telmisartan on insulin resistance and fatty liver in patients suffer from hypertension - InReTel

• Conditions: Influence of Telmisartan on insulin resistance, hypertension, non-alcoholic fatty liver; MedDRA version: 12.0Level: LLTClassification code 10020772Term: Hypertension; MedDRA version: 12.0Level: LLTClassification code 10052066Term: Metabolic syndrome; MedDRA version: 12.0Level: LLTClassification code 10022489Term: Insulin resistance; MedDRA version: 12.0Level: LLTClassification code 10016261Term: Fatty liver

• Registration Number: EUCTR2009-015703-13-DE
• Lead Sponsor: Klinik für Innere Medizin II der Klinikum Chemnitz gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-02
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified