EUCTR2008-000815-13-DE
Active, not recruiting
Not Applicable
Analysis of cerebral, renal, peripheral, and retinal hemodynamics in adults with type 2 diabetes before, during, and after administration of pioglitazone or placebo.
Technical University Munich0 sitesApril 3, 2008
ConditionsConsidering the existing data, Actos (pioglitazone) is a promising candidate to improve hemodynamics of various vascular beds by positive effects on endothelial function. This study aims to analyse cerebral, renal, peripheral, and ocular hemodynamics in adults with type 2 diabetes before, during, and after administration of Actos or placebo using the CO2 inhalation test, the Inulin and Paraaminohippuric acid renal clearance, the Venous occlusion plethysmography, and the Retinal Vessel Analyzer.MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus
DrugsActos
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Considering the existing data, Actos (pioglitazone) is a promising candidate to improve hemodynamics of various vascular beds by positive effects on endothelial function. This study aims to analyse cerebral, renal, peripheral, and ocular hemodynamics in adults with type 2 diabetes before, during, and after administration of Actos or placebo using the CO2 inhalation test, the Inulin and Paraaminohippuric acid renal clearance, the Venous occlusion plethysmography, and the Retinal Vessel Analyzer.
- Sponsor
- Technical University Munich
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •Age 18 \- 95 years
- •Fasting blood sugar (FBS) \> 200 mg/dl and / or HbA1c \> 5,9% or antidiabetic treatment
- •Adequate bilateral temporal bone windows for sufficient TCD examination and symmetrical perfusion of the middle cerebral artery (MCA)
- •Cardio\- / cerebrovascular disease
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •General Exclusion Criteria
- •Participation in another pharmacologic study in the last 30 days
- •Known or possible pregnancy or breastfeeding
- •Cognitive impairment or other reasons interfering with patient compliance
- •Known malignancy in the last 5 years
- •Specific Exclusion Criteria
- •Hemodynamically relevant stenoocclusive disease of the extracranial and / or intracranial cerebral arteries diagnosed by doppler sonography
- •TIA or stroke in the last 3 months
- •Carotid endarteriectomy or angioplasty in the last 3 months
- •Insulin dependency
Outcomes
Primary Outcomes
Not specified
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