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Completed

NCT Number: NCT00154011

Investigation of Vascular Relaxing Effects of the Antidiabetic Rosiglitazone.

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Clinical Pharmacology

Dresden, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

rosiglitazone (drug)

Drug

Primary outcomes

  1. Vascular reactivity after 8 weeks treatment.

Secondary outcomes

  1. Changes in angiotensin peptide metabolism.

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

Characterization of Vascular Effects of Rosiglitazone.

Important dates

Study start
2005
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Sep 12, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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