Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
Information source: Ludwig-Maximilians - University of Munich
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Metabolic Syndrome; Hypertriglyceridemia
Intervention: telmisartan (Drug); telmisartan (Drug); placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Ludwig-Maximilians - University of Munich Official(s) and/or principal investigator(s):
Klaus G Parhofer, MD, Principal Investigator, Affiliation: Ludwig-Maximilians - University of Munich
Overall contact:
Klaus G Parhofer, MD, Phone: ++49-89-7095-3010, Email: klaus.parhofer@med.uni-muenchen.de
Summary
A number of studies have shown that certain blood-pressure medications such as
ACE-inhibitors and angiotensin-II-receptor blockers (ARB) can reduce the incidence of
diabetes mellitus type 2. This protocol will evaluate whether inflammatory mechanisms
mediate this effect. We therefore will investigate the effect of telmisartan, a potent ARB,
on lipid metabolism, glucose metabolism and inflammation in patients with the metabolic
syndrome. Specific parameters will be tested before treatment and after 3 months of
treatment. Placobo will be compared to 2 different doses of telmisartan per day.
Clinical Details
Official title: Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: change in IL-6
Secondary outcome: change in fasting lipids;
change in postprandial lipids;
change in inflammatory parameters;
change in glucose metabolism;
Eligibility
Minimum age: 19 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Abd. obesity (BMI>25kg/m²) and waist circumference ≥95cm (men),≥80cm (women)
- Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
- Triglycerides 150-400 mg/dl
- Normal stress test
- Normal carotid ultrasound
- Normal fundoscopy
Exclusion Criteria:
- Diabetes mellitus
- Secondary cause for insulin resistance
- LDL-cholesterol >190 mg/dl
- Atherosclerotic disease
- Blood pressure >160 mmHg (systolic) and/or >100 mmHg (diastolic)
- Regular alcohol consumption (>30 g/day)
- Contraindication against telmisartan
- Antihypertensive medications
- Lipid lowering therapy
- Malignancy
- Pregnancy or Lactation
- Women without adequate contraception
Locations and Contacts
Klaus G Parhofer, MD, Phone: ++49-89-7095-3010, Email: klaus.parhofer@med.uni-muenchen.de
Med. Dept. 2, University Munich, Munich 81377, Germany; Recruiting
Klaus G Parhofer, MD, Phone: +49-89-7095-3010, Email: klaus.parhofer@med.uni-muenchen.de
Burkhard Goke, MD, Phone: +49-89-7095-3010
Klaus G Parhofer, MD, Principal Investigator
Center for Cardiovascular Research, University Berlin, Berlin 10115, Germany; Recruiting
Ulrich Kintscher, MD, Phone: +49-30-450525276, Email: ulrich.kintscher@charite.de
Thomas Unger, MD, Phone: +49-30-450525276
Ulrich Kintscher, MD, Principal Investigator
Additional Information
Starting date: November 2007
Ending date: June 2009
Last updated: May 5, 2008
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