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

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ClinicalTrials.gov Identifier: NCT00560430
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : July 15, 2010
Sponsor:
Collaborator:
Bayer
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

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
U.S. FDA Resources

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
placebo
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 ]


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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

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


Locations
Germany
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
Bayer
Investigators
Principal Investigator: Klaus G Parhofer, MD Ludwig-Maximilians - University of Munich

Responsible Party: Klaus Parhofer, Principal investigator, Ludwig-Maximilians - University of Munich, Med. Dept. 2,
ClinicalTrials.gov Identifier: NCT00560430     History of Changes
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:
Metabolic Syndrome X
Hypertriglyceridemia
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action