Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

Hypertension Clinical Trial

— METATEL  

Official title:

Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560430
• Other study ID #: KPUK0106
• Secondary ID: EudraCT 2006-003
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2007
• Last updated: July 14, 2010
• Start date: November 2007
• Est. completion date: October 2009

Study information

• Verified date: May 2008
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypertension
• Hypertriglyceridemia
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• telmisartan
80 mg per day, orally, weeks 1-14
• telmisartan
80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14
• placebo
placebo; orally weeks 1-14

Locations

Country	Name	City	State
Germany	Center for Cardiovascular Research, University Berlin	Berlin
Germany	Med. Dept. 2, University Munich	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in IL-6		14 weeks	No
Secondary	change in fasting lipids;		14 weeks	No
Secondary	change in postprandial lipid metabolism		14 weeks	No
Secondary	change in inflammatory parameters		14 weeks	No
Secondary	change in glucose metabolism		14 weeks	No