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Investigation of Vascular Relaxing Effects of the Antidiabetic Rosiglitazone.

NCT ID: NCT00154011

Last Updated: 2006-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Subjects

Keywords

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vascular reactivity, venodilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rosiglitazone (drug)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Principal Investigators

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Wilhelm Kirch, MD

Role: STUDY_CHAIR

Institute of Clinical Pharmacology

Locations

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Institute of Clinical Pharmacology

Dresden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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IKPD 01-05

Identifier Type: -

Identifier Source: org_study_id