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. We 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. Placobo will be compared to 2 different doses of telmisartan per day.

Study Type: Interventional

Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2009

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; change in postprandial lipids; change in inflammatory parameters; 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 Sponsor: Ludwig-Maximilians - University of Munich

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Klaus G Parhofer, MD ++49-89-7095-3010 klaus.parhofer@med.uni-muenchen.de

Information obtained from ClinicalTrials.gov on July 02, 2009

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