Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Hypertension Metabolic Syndrome Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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T1

Telmisartan 80 mg/d

Group Type ACTIVE_COMPARATOR

telmisartan

Intervention Type DRUG

80 mg per day, orally, weeks 1-14

T2

Telmisartan 160 mg/d

Group Type ACTIVE_COMPARATOR

telmisartan

Intervention Type DRUG

80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14

P

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo; orally weeks 1-14

Interventions

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telmisartan

80 mg per day, orally, weeks 1-14

Intervention Type DRUG

telmisartan

80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14

Intervention Type DRUG

placebo

placebo; orally weeks 1-14

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No