Effect of direct renin-inhibition aliskiren on renal haemodynamic and metabolic parameters in patients with prediabetes - AMARYLIS

• Conditions: Patients with prediabetes (either impaired glucose tolerance or imparied fasting glucose) and no obvious diabetes mellitus; MedDRA version: 14.1Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2008-008287-28-DE
• Lead Sponsor: niversity Hospital Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-13
• Last Update Posted: 31 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Adults aged > 18 to < 70 years
Prediabetes (HbA1c 5.7-6.4 %) impaired fasting glucose (blood glucose 100 - 126 mg/dl) or impaired glucose tolerance (IGT) (Blood glucose > 140 mg/dl and < 200 mg/dl 2 h after an oral glucose administration of 75g)
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified