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

• ClinicalTrials.gov Identifier: NCT00560430
• Recruitment Status: Completed
• First Posted: November 19, 2007
• Last Update Posted: July 15, 2010
• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborator: Bayer
• Information provided by: Ludwig-Maximilians - University of Munich

Tracking Information

• First Submitted Date: November 16, 2007
• First Posted Date: November 19, 2007
• Last Update Posted Date: July 15, 2010
• Study Start Date: November 2007
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 16, 2007): change in IL-6 [ Time Frame: 14 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 14, 2010)

• change in fasting lipids; [ Time Frame: 14 weeks ]
• change in postprandial lipid metabolism [ Time Frame: 14 weeks ]
• change in inflammatory parameters [ Time Frame: 14 weeks ]
• change in glucose metabolism [ Time Frame: 14 weeks ]

• Original Secondary Outcome Measures (submitted: November 16, 2007): change in fasting lipids; change in postprandial lipids; change in inflammatory parameters; change in glucose metabolism; [ Time Frame: 14 weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
• Official Title: Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science

Condition

• Hypertension
• Metabolic Syndrome
• Hypertriglyceridemia

Intervention

• Drug: telmisartan
  80 mg per day, orally, weeks 1-14
• Drug: telmisartan
  80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14
• Drug: placebo
  placebo; orally weeks 1-14

Study Arms

• Active Comparator: T1
  Telmisartan 80 mg/d
  Intervention: Drug: telmisartan
• Active Comparator: T2
  Telmisartan 160 mg/d
  Intervention: Drug: telmisartan
• Placebo Comparator: P
  placebo
  Intervention: Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 14, 2010): 56
• Original Estimated Enrollment (submitted: November 16, 2007): 0
• Actual Study Completion Date: October 2009
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00560430
• Other Study ID Numbers: KPUK0106; EudraCT 2006-003567-31
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Klaus Parhofer, Principal investigator, Ludwig-Maximilians - University of Munich, Med. Dept. 2,
• Original Responsible Party: Not Provided
• Current Study Sponsor: Ludwig-Maximilians - University of Munich
• Original Study Sponsor: Same as current
• Collaborators: Bayer

Investigators

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

• PRS Account: Ludwig-Maximilians - University of Munich
• Verification Date: May 2008