Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

Phase 3

Completed

• Conditions: Hypertension; Metabolic Syndrome; Hypertriglyceridemia
• Interventions: Drug: placebo; Drug: telmisartan

• Registration Number: NCT00560430
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-19
• Status Verified: 2008-05
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Last Update Submitted: 2010-07-14
• Last Update Posted: 2010-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	placebo	placebo
T1	telmisartan	Telmisartan 80 mg/d
T2	telmisartan	Telmisartan 160 mg/d

Primary Outcome Measures

Name	Time	Method
change in IL-6	14 weeks

Secondary Outcome Measures

Name	Time	Method
change in fasting lipids;	14 weeks
change in postprandial lipid metabolism	14 weeks
change in inflammatory parameters	14 weeks
change in glucose metabolism	14 weeks

Trial Locations

Locations (2)

Center for Cardiovascular Research, University Berlin; 🇩🇪 Berlin, Germany

Med. Dept. 2, University Munich; 🇩🇪 Munich, Germany