The influence of Telmisartan on insulin resistance and fatty liver in patients suffer from hypertensio

Completed

• Conditions: Insulin resistance; fatty liver; hypertension; metabolic syndrome; Nutritional, Metabolic, Endocrine; Essential (primary) hypertension

• Registration Number: ISRCTN03070108
• Lead Sponsor: Klinikum Chemnitz gGmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of insulin resistance reflected by normalised or increased ISI-Matsuda (> 4) 6 months after treatment