Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
InReTel
Study information
Scientific title
The influence of Telmisartan on insulin resistance and fatty liver in patients suffer from hypertension: A phase IV, randomised controlled trial.
Acronym
InReTel
Study hypothesis
To determine the efficacy of Telmisartan on insulin resistance and fatty liver in patients suffer from hypertension
Ethics approval
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)
Study design
Prospective phase IV open label randomised controlled parallel group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
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 names
Telmisartan, amlodipin, bisoprolol, torasemid
Primary outcome measure
Improvement of insulin resistance reflected by normalised or increased ISI-Matsuda (> 4) 6 months after treatment
Secondary outcome measures
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
Overall trial start date
15/02/2010
Overall trial end date
30/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
72
Participant 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
Recruitment start date
15/02/2010
Recruitment end date
30/09/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Internal Medicine
Chemnitz
09116
Germany
Funders
Funder type
Industry
Funder name
Bayer Vital GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list