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

Primary Purpose

Hypertension, Metabolic Syndrome, Hypertriglyceridemia

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
telmisartan
telmisartan
placebo
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertension

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Center for Cardiovascular Research, University Berlin
  • Med. Dept. 2, University Munich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

T1

T2

P

Arm Description

Telmisartan 80 mg/d

Telmisartan 160 mg/d

placebo

Outcomes

Primary Outcome Measures

change in IL-6

Secondary Outcome Measures

change in fasting lipids;
change in postprandial lipid metabolism
change in inflammatory parameters
change in glucose metabolism

Full Information

First Posted
November 16, 2007
Last Updated
July 14, 2010
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00560430
Brief Title
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
Acronym
METATEL
Official Title
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Metabolic Syndrome, Hypertriglyceridemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T1
Arm Type
Active Comparator
Arm Description
Telmisartan 80 mg/d
Arm Title
T2
Arm Type
Active Comparator
Arm Description
Telmisartan 160 mg/d
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
telmisartan
Intervention Description
80 mg per day, orally, weeks 1-14
Intervention Type
Drug
Intervention Name(s)
telmisartan
Intervention Description
80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo; orally weeks 1-14
Primary Outcome Measure Information:
Title
change in IL-6
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
change in fasting lipids;
Time Frame
14 weeks
Title
change in postprandial lipid metabolism
Time Frame
14 weeks
Title
change in inflammatory parameters
Time Frame
14 weeks
Title
change in glucose metabolism
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus G Parhofer, MD
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Cardiovascular Research, University Berlin
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
Med. Dept. 2, University Munich
City
Munich
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

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Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

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