Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
Information source: Ludwig-Maximilians - University of Munich
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed
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
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. The investigators 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. Placebo 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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: change in IL-6
Secondary outcome: change in fasting lipids;change in postprandial lipid metabolism 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
Center for Cardiovascular Research, University Berlin, Berlin 10115, Germany
Med. Dept. 2, University Munich, Munich 81377, Germany
Additional Information
Starting date: November 2007
Last updated: July 14, 2010
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