NCT00407862

Brief Summary

Inhibition of RAS delays onset of diabetes in clinical studies. Preliminary evidence suggests that telmisartan may have unique metabolic properties compared to other ARB due to activation of PPARγ. This should be tested in comparison with an ARB that is metabolically neutral in already published studies. H0: Telmisartan is not different from Losartan with respect to metabolic and vascular effects. H1: Telmisartan is different from Losartan with respect to metabolic and vascular effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

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

January 1, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
Last Updated

December 5, 2006

Status Verified

December 1, 2006

First QC Date

December 4, 2006

Last Update Submit

December 4, 2006

Conditions

HypertensionImpaired Glucose Tolerance

Keywords

insulin resistancebeta cell functionendothelial dysfunction

Outcome Measures

Primary Outcomes (4)

  • HOMA index

  • ISI

  • FMD

  • Blood pressure surge in the morning

Interventions

Telmisartan 80 mgDRUG
Losartan 50 mgDRUG

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IGT according the criteria of the WHO
  • standardised office blood pressure \> 140/90 mmHG or treated hypertension
  • years of age
  • signed informed consent

You may not qualify if:

  • known hypersensitivity towards telmisartan or losartan
  • concommitant treatment with ACE-inhibitors
  • BMI \> 35 kg/m2
  • inability to perform self-control of blood pressure
  • acute coronary syndrome or cerebrovascular event within the last 3 months
  • Revascularisation within the last 3 months
  • heart failure \> NYHA 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

HypertensionGlucose IntoleranceInsulin Resistance

Interventions

TelmisartanLosartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingTetrazoles

Study Officials

  • Thomas C. Wascher, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 5, 2006

Study Start

January 1, 2005

Study Completion

June 1, 2006

Last Updated

December 5, 2006

Record last verified: 2006-12

Locations

AU(1)