Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation (ROTATE-1)

Phase 4

Completed

Conditions: Albuminuria in patients with diabetes
10029149

Registration Number: NL-OMON43438

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 17

Inclusion Criteria

* Type 1 diabetes
* eGFR > 45ml/min/1.73m2
* Albumin:creatinine ratio >50mg/g and *500 mg/g
* Age * 18 years
* Written informed consent

Exclusion Criteria

* Pregnant women and women of child-bearing potential who are not using
reliable contraception
* Cardiovascular disease: myocardial infarction, angina pectoris,
percutanous transluminal coronary angioplasty, coronary artery bypass
grafting, stroke, heart failure (NYHA I-IV) < 6 months before inclusion
* Uncontrolled blood pressure (office bp > 160/ 100 mmHg)
* Known malignancy
* History of autonomic dysfunction (e.g. history of fainting or clinically
significant orthostatic hypotension)
* Any medication, surgical or medical condition which might significantly alter
the absorption, distribution, metabolism, or excretion of medications

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective:<br /><br>To determine the degree of albuminuria lowering response of four different<br /><br>albuminuria lowering drug classes in individual patients with type 1 diabetes<br /><br>and microalbuminuria.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s):<br /><br>* To correlate the albuminuria-lowering response within individuals between<br /><br>different drug classes.<br /><br>* To correlate the albuminuria-lowering response within individuals with the<br /><br>thickness of the glycocalyx.</p><br>