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.
Conditions
Interventions
Trade Name: Actos
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Technical University Munich
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 • Diabetic ketoacidosis • Body mass index (BMI) > 35 kg/m2 • Premedication with thiazolidindiones • Start of treatment with statins in the last 3 months • Start of treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers in the last 3 months • Known drug intolerance against thiazolidindiones • Known drug intolerance against indicator substances (PAH, IN) • Known drug intolerance against tropicamide • Known liver disease (GOT and / or GPT > 2.5 x upper normal limit) • Known renal insufficiency (serum creatinine > 1.2 mg/dl and / or creatinine clearance < 30 ml/min according to the Cockroft formula) • Known microalbuminuria • Known anaemia (haemoglobin < 11 g/dl (male), < 10 g/dl (female)) • Known heart insufficiency (NYHA I-IV) • Advanced pulmonary disease • Known angle-closure glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Changes in the cerebral vasomotor reactivity (CVMR) during and 2 weeks after pioglitazone treatment compared to baseline and placebo;Secondary Objective: Changes in the renal glomerular filtration rate (GFR) and renal plasma flow (RPF), the forearm blood flow (FBF), and the retinal vascular reactivity during and 2 weeks after pioglitazone treatment compared to baseline and placebo;Primary end point(s): Changes in the cerebral vasomotor reactivity (CVMR) from baseline to end of treatment | — |
Countries
Germany
Outcome results
None listed