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

This study has been completed.
Information provided by:
Ludwig-Maximilians - University of Munich Identifier:
First received: November 16, 2007
Last updated: July 14, 2010
Last verified: May 2008
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 Intervention Phase
Hypertension Metabolic Syndrome Hypertriglyceridemia Drug: telmisartan Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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

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

Secondary Outcome Measures:
  • change in fasting lipids; [ Time Frame: 14 weeks ]
  • change in postprandial lipid metabolism [ Time Frame: 14 weeks ]
  • change in inflammatory parameters [ Time Frame: 14 weeks ]
  • change in glucose metabolism [ Time Frame: 14 weeks ]

Enrollment: 56
Study Start Date: November 2007
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00560430

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
Principal Investigator: Klaus G Parhofer, MD Ludwig-Maximilians - University of Munich
  More Information

Responsible Party: Klaus Parhofer, Principal investigator, Ludwig-Maximilians - University of Munich, Med. Dept. 2, Identifier: NCT00560430     History of Changes
Other Study ID Numbers: KPUK0106
EudraCT 2006-003567-31
Study First Received: November 16, 2007
Last Updated: July 14, 2010

Additional relevant MeSH terms:
Metabolic Syndrome X
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 processed this record on September 21, 2017