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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

Page last updated: August 23, 2015

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