Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients (METATEL)

Ludwig Maximilian University of Munich

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hypertriglyceridemia; Metabolic Syndrome

Treatments: Drug: telmisartan; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00560430

EudraCT 2006-003567-31

KPUK0106

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

56 participants in 3 patient groups, including a placebo group

T1

Active Comparator group

Description:

Telmisartan 80 mg/d

Treatment:

Drug: telmisartan

Drug: telmisartan

T2

Active Comparator group

Description:

Telmisartan 160 mg/d

Treatment:

Drug: telmisartan

Drug: telmisartan

P

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo