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. Identifier: NCT00560430
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : July 15, 2010
Information provided by:
Ludwig-Maximilians - University of Munich

November 16, 2007
November 19, 2007
July 15, 2010
November 2007
September 2009   (Final data collection date for primary outcome measure)
change in IL-6 [ Time Frame: 14 weeks ]
Same as current
Complete list of historical versions of study NCT00560430 on Archive Site
  • 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 ]
change in fasting lipids; change in postprandial lipids; change in inflammatory parameters; change in glucose metabolism; [ Time Frame: 14 weeks ]
Not Provided
Not Provided
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Hypertension
  • Metabolic Syndrome
  • Hypertriglyceridemia
  • Drug: telmisartan
    80 mg per day, orally, weeks 1-14
  • Drug: telmisartan
    80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14
  • Drug: placebo
    placebo; orally weeks 1-14
  • Active Comparator: T1
    Telmisartan 80 mg/d
    Intervention: Drug: telmisartan
  • Active Comparator: T2
    Telmisartan 160 mg/d
    Intervention: Drug: telmisartan
  • Placebo Comparator: P
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2009
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
EudraCT 2006-003567-31
Not Provided
Not Provided
Klaus Parhofer, Principal investigator, Ludwig-Maximilians - University of Munich, Med. Dept. 2,
Ludwig-Maximilians - University of Munich
Principal Investigator: Klaus G Parhofer, MD Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP