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

ISRCTN	ISRCTN03070108
DOI	https://doi.org/10.1186/ISRCTN03070108
Protocol serial number	InReTel
Sponsor	Klinikum Chemnitz gGmbH (Germany)
Funder	Bayer Vital GmbH (Germany)

Submission date: 09/02/2010
Registration date: 05/03/2010
Last edited: 05/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ulrich Stölzel
Scientific

Department of Internal Medicine
Klinikum Chemnitz gGmbH
Flemmingstrasse 2
Chemnitz
09116
Germany

Study information

Primary study design	Interventional
Study design	Prospective phase IV open label randomised controlled parallel group study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The influence of Telmisartan on insulin resistance and fatty liver in patients suffer from hypertension: A phase IV, randomised controlled trial.
Study acronym	InReTel
Study objectives	To determine the efficacy of Telmisartan on insulin resistance and fatty liver in patients suffer from hypertension
Ethics approval(s)	The Saxon State Medical Association Ethics Commission (Ethikkommission bei der Sächsischen Landesärztekammer) approved on the 11th of December 2009 (ref: EK-AMG-MO-2/09-1)
Health condition(s) or problem(s) studied	Insulin resistance; fatty liver; hypertension; metabolic syndrome
Intervention	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. Control arm: treatment of hypertension with standard therapy w/o sartans, preferred: Amlodipin, Bisoprolol and/ or Torasemid, oral use - dependent on compliance of patients Total duration of treatment per patient: 6 months, w/o follow-up. The total duration of follow-up post-treatment will be 12 months.
Intervention type	Drug
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Telmisartan, amlodipin, bisoprolol, torasemid
Primary outcome measure(s)	Improvement of insulin resistance reflected by normalised or increased ISI-Matsuda (> 4) 6 months after treatment
Key secondary outcome measure(s)	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
Completion date	30/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	72
Key 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
Key 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
Date of first enrolment	15/02/2010
Date of final enrolment	30/09/2011

Locations

Countries of recruitment

Germany

Study participating centre

Department of Internal Medicine

Chemnitz
09116
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes