Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients - Full Text View

Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients (METATEL)

This study is currently recruiting participants.

Verified by Ludwig-Maximilians - University of Munich, May 2008

First Received: November 16, 2007 Last Updated: May 5, 2008 History of Changes

Sponsor:	Ludwig-Maximilians - University of Munich
Collaborator:	Bayer
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00560430

Purpose

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.

Condition	Intervention	Phase
Hypertension Metabolic Syndrome Hypertriglyceridemia	Drug: telmisartan Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Triglycerides

Drug Information available for: Telmisartan

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:

change in IL-6 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in fasting lipids; change in postprandial lipids; change in inflammatory parameters; change in glucose metabolism; [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	0
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
T1: Active Comparator Telmisartan 80 mg/d	Drug: telmisartan 80 mg per day, orally, weeks 1-14
T2: Active Comparator Telmisartan 160 mg/d	Drug: telmisartan 80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14
P: Placebo Comparator placebo	Drug: placebo placebo; orally weeks 1-14

Eligibility

Ages Eligible for Study:	19 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560430

Contacts

Contact: Klaus G Parhofer, MD	++49-89-7095-3010	klaus.parhofer@med.uni-muenchen.de
Contact: Ulrich Kintscher, MD	++49-30-450-525276	ulrich.kintscher@charite.de

Locations

Germany
Med. Dept. 2, University Munich	Recruiting
Munich, Germany, 81377
Contact: Klaus G Parhofer, MD +49-89-7095-3010 klaus.parhofer@med.uni-muenchen.de
Contact: Burkhard Goke, MD +49-89-7095-3010
Principal Investigator: Klaus G Parhofer, MD
Center for Cardiovascular Research, University Berlin	Recruiting
Berlin, Germany, 10115
Contact: Ulrich Kintscher, MD +49-30-450525276 ulrich.kintscher@charite.de
Contact: Thomas Unger, MD +49-30-450525276
Principal Investigator: Ulrich Kintscher, MD

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Bayer

Investigators

Principal Investigator:

Klaus G Parhofer, MD

Ludwig-Maximilians - University of Munich

More Information

No publications provided

Responsible Party:	Ludwig-Maximilians - University of Munich, Med. Dept. 2, ( Klaus Parhofer, Principal investigator )
Study ID Numbers:	KPUK0106, EudraCT 2006-003567-31
Study First Received:	November 16, 2007
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00560430 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Hypertriglyceridemia
Hyperlipidemias
Metabolic Diseases
Disease
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

Angiotensin II Type 1 Receptor Blockers
Pathologic Processes
Syndrome
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 20, 2009