Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: T1
  • Telmisartan 80 mg/d
• Active Comparator: T2
  • Telmisartan 160 mg/d
• Placebo Comparator: P
  • placebo

Primary Measures

• change in IL-6
  • Time Frame: 14 weeks
    Safety Issue?: No

Secondary Measures

• change in fasting lipids;
  • Time Frame: 14 weeks
    Safety Issue?: No
• change in postprandial lipid metabolism
  • Time Frame: 14 weeks
    Safety Issue?: No
• change in inflammatory parameters
  • Time Frame: 14 weeks
    Safety Issue?: No
• change in glucose metabolism
  • Time Frame: 14 weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Ludwig-Maximilians - University of Munich Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00560430

Study ID Number: KPUK0106

ClinicalTrials.gov Identifier: NCT00560430

Health Authority: Germany: Federal Institute for Drugs and Medical Devices