NCT00560430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Nov 2007

Typical duration for phase_3 hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 15, 2010

Status Verified

May 1, 2008

Enrollment Period

1.8 years

First QC Date

November 16, 2007

Last Update Submit

July 14, 2010

Conditions

HypertensionMetabolic SyndromeHypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • change in IL-6

    14 weeks

Secondary Outcomes (4)

  • 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

Study Arms (3)

T1

ACTIVE COMPARATOR

Telmisartan 80 mg/d

Drug: telmisartan

T2

ACTIVE COMPARATOR

Telmisartan 160 mg/d

Drug: telmisartan

P

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

telmisartanDRUG

80 mg per day, orally, weeks 1-14

T1
placeboDRUG

placebo; orally weeks 1-14

P

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Cardiovascular Research, University Berlin

Berlin, 10115, Germany

Location

Med. Dept. 2, University Munich

Munich, 81377, Germany

Location

MeSH Terms

Conditions

HypertensionMetabolic SyndromeHypertriglyceridemia

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Klaus G Parhofer, MD

    Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

November 1, 2007

Primary Completion

September 1, 2009

Study Completion

October 1, 2009

Last Updated

July 15, 2010

Record last verified: 2008-05

Locations

DE(2)