Patients with prediabetes (either impaired glucose tolerance or imparied fasting glucose) and no obvious diabetes mellitus MedDRA version: 14.1 Level: LLT Classification code 10065542 Term: Prediabetes System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Rasilez 150 mg
Product Name: Rasilez
Pharmaceutical Form: Tablet
Trade Name: Rasilez 300 mg
Product Name: Rasilez
Pharmaceutical Form: Tablet
Sponsors
University Hospital Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged > 18 to 140 mg/dl and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Diabetes Mellitus Type 1/2 Micro-, or Macroalbuminuria Renal insufficiency Secondary forms of arterial hypertension Ongoing therapy with ACE-Inhibitors, AT1 blocker, direct renin inhibitor Antihypertensive therapy with more than 2 agents Uncontrolled Blood pressure Known intolerance of direct renin inhibitor Medical history of cerebral stroke or myocardial infarction within the last 6 months, chronic heart failure NYHA III-IV Severe gastrointestinal disease Elevated liver parameters (SGOT, SGPT > more than doubled) Tablet or alcohol abuse Adipositas per magna (BMI > 35kg/m²) Malignant disease Insufficient Compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of this study is to examine the effect of Aliskiren (150mg/daily for 1 week, 300 mg/daily for 4 weeks) on renal hemodynamics in patients with prediabetes and eleveted blood pressure.;Secondary Objective: The effect of a 5 week lasting therapy with Aliskiren on metabolic parameters (HbA1c, high sensitive CRP, Adiponectin), in patients with impaired glucose tolerance and arterial. ;Primary end point(s): Renal haemodynamic parameters (glomerular filtration rate, renal plasma flow, filtration fraction) under direct renin blockade | — |
Countries
Germany
Outcome results
None listed