Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00560430

Acronym

METATEL

Enrollment

Registered

2007-11-19

Start date

2007-11-30

Completion date

2009-10-31

Last updated

2010-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Hypertriglyceridemia, Metabolic Syndrome

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.

Interventions

DRUGtelmisartan

80 mg per day, orally, weeks 1-14

DRUGplacebo

placebo; orally weeks 1-14

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
change in IL-6	14 weeks

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026