The influence of Telmisartan on insulin resistance and fatty liver in patients suffer from hypertension
| ISRCTN | ISRCTN03070108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03070108 |
| Secondary identifying numbers | InReTel |
- 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
Scientific
Department of Internal Medicine
Klinikum Chemnitz gGmbH
Flemmingstrasse 2
Chemnitz
09116
Germany
Study information
| Study design | Prospective phase IV open label randomised controlled parallel group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/02/2010 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
09116
Germany
Sponsor information
Klinikum Chemnitz gGmbH (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof. Dr. Stölzel (legal representative)
Flemmingstrasse 2
Chemnitz
09116
Germany
"ROR" |
https://ror.org/04wkp4f46 |
|---|
Funders
Funder type
Industry
Bayer Vital GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
