METATEL: Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

• Sponsor: Ludwig-Maximilians - University of Munich (Other)
• Overall Status: Completed
• CT.gov ID: NCT00560430
• Collaborator: Bayer (Industry)
• Enrollment: 56
• Locations: 2
• Arms: 3
• Duration (Months): 23
• Patients Per Site: 28
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Metabolic Syndrome; Hypertriglyceridemia	Drug: telmisartan; Drug: telmisartan; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: T1 Telmisartan 80 mg/d	Drug: telmisartan; 80 mg per day, orally, weeks 1-14
Active Comparator: T2 Telmisartan 160 mg/d	Drug: telmisartan; 80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14
Placebo Comparator: P placebo	Drug: placebo; placebo; orally weeks 1-14

Outcome Measures

Primary Outcome Measures

1. change in IL-6 [14 weeks]

Secondary Outcome Measures

1. change in fasting lipids; [14 weeks]

2. change in postprandial lipid metabolism [14 weeks]

3. change in inflammatory parameters [14 weeks]

4. change in glucose metabolism [14 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Cardiovascular Research, University Berlin	Berlin		Germany	10115
2	Med. Dept. 2, University Munich	Munich		Germany	81377

Sponsors and Collaborators

• Ludwig-Maximilians - University of Munich
• Bayer

Investigators

• Principal Investigator: Klaus G Parhofer, MD, Ludwig-Maximilians - University of Munich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00560430
• Other Study ID Numbers: KPUK0106; EudraCT 2006-003567-31
• First Posted: Nov 19, 2007
• Last Update Posted: Jul 15, 2010
• Last Verified: May 1, 2008

• Additional relevant MeSH terms: Metabolic Syndrome; Hypertriglyceridemia; Telmisartan

Study Results

No Results Posted as of Jul 15, 2010