We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00560430
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : July 15, 2010
Information provided by:
Ludwig-Maximilians - University of Munich

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Metabolic Syndrome Hypertriglyceridemia Drug: telmisartan Drug: placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
Study Start Date : November 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Active Comparator: T1
Telmisartan 80 mg/d
Drug: telmisartan
80 mg per day, orally, weeks 1-14

Active Comparator: T2
Telmisartan 160 mg/d
Drug: telmisartan
80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14

Placebo Comparator: P
Drug: placebo
placebo; orally weeks 1-14

Primary Outcome Measures :
  1. change in IL-6 [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. change in fasting lipids; [ Time Frame: 14 weeks ]
  2. change in postprandial lipid metabolism [ Time Frame: 14 weeks ]
  3. change in inflammatory parameters [ Time Frame: 14 weeks ]
  4. change in glucose metabolism [ Time Frame: 14 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560430

Layout table for location information
Center for Cardiovascular Research, University Berlin
Berlin, Germany, 10115
Med. Dept. 2, University Munich
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Layout table for investigator information
Principal Investigator: Klaus G Parhofer, MD Ludwig-Maximilians - University of Munich
Layout table for additonal information
Responsible Party: Klaus Parhofer, Principal investigator, Ludwig-Maximilians - University of Munich, Med. Dept. 2,
ClinicalTrials.gov Identifier: NCT00560430    
Other Study ID Numbers: KPUK0106
EudraCT 2006-003567-31
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: July 15, 2010
Last Verified: May 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action