Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/02/2010
Date assigned
05/03/2010
Last edited
05/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ulrich Stölzel

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Klinikum Chemnitz gGmbH (Germany)

Sponsor details

c/o Prof. Dr. Stölzel (legal representative)
Flemmingstrasse 2
Chemnitz
09116
Germany

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes