CClinicalTrials.gg
CompletedNCT00154011Updated Sep 12, 2006

Investigation of Vascular Relaxing Effects of the Antidiabetic Rosiglitazone.

An interventional study of rosiglitazone (drug) in Healthy Subjects, sponsored by Technische Universität Dresden. Completed at 1 site in Germany. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-09-12.

Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

The study is designed to test the hypothesis in healthy subjects that the oral antidiabetic drug rosiglitazone provides additional vascular relaxing or modulating effects in addition to its blood glucose level reducing ability.

Read the detailed description

The aim of the study is to investigate the effect of oral rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Rosiglitazone will be given orally (4 weeks 4mg/d, titrated to 8 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with rosiglitazone.

02

Conditions studied

  • Healthy Subjects

Keywords

  • vascular reactivity, venodilation
03

In context

Lead sponsor

Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male
  • Healthy
  • 18 - 40 years old
  • Non-smoker
  • No additional medication

Exclusion criteria

Exclusion Criteria:

  • Any relevant disease
  • Smokers
  • Elevated liver enzymes
  • Body weight different from Broca norm > 20%
  • Allergies
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
24 participants

Interventions

  • Drugrosiglitazone (drug)
06

What researchers measure

Primary outcomes

  1. Vascular reactivity after 8 weeks treatment.

Secondary outcomes

  1. Changes in angiotensin peptide metabolism.

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Study locations

1 site
  • Institute of Clinical Pharmacology
    Dresden, 01307, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00154011
Lead sponsor
Technische Universität Dresden
First posted
Sep 12, 2005
Start date
Sep 2005
Completion
Jun 2006
Last update
Sep 12, 2006

Study contacts

Wilhelm Kirch, MD
study chair · Institute of Clinical Pharmacology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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