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Completed

NCT Number: NCT00560430

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Hypertriglyceridemia Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Center for Cardiovascular Research, University Berlin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan

Drug

80 mg per day, orally, weeks 1-14

Placebo

Drug

placebo; orally weeks 1-14

Primary outcomes

  1. change in IL-6

    Time frame: 14 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Bayer

Registry information

Acronym: METATEL

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2007
Registry last updated
Jul 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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