Mechanisms of Albuminuria in Diabetes: Reversal of Injury to the Glycocalyx by the Ace-inhibitor Lisinopril

Phase 4

• Conditions: 10012653; 10029149; 10003216; diabetes mellitus; Type 1 diabetes

• Registration Number: NL-OMON32380
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Caucasian
Male
Diagnosis of type 1 diabetes according to ADA criteria
Urinary albumin/creatinin ratio <3,5 mg/mmol, without antiproteinuric treatment

Exclusion Criteria

Hypertension as defined by systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg or use of antihypertensive drugs
Previous use of RAS inhibitors
Smoking
Primary dyslipidemia*s
Use of statins during the six weeks before visit 1
Use of antioxidants in the two weeks prior to visit 1
Angioedema in medical history
Hypersensitivity to Ace inhibitors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameter of the study is the change in microvascular glycocalyx<br /><br>thickness before and after treatment with lisinopril and placebo.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary parameters of the study are change in blood pressure,<br /><br>microalbuminuria, glomerular charge selectivity, plasmalevels of hyaluronan,<br /><br>hyaluronidase,vWf and prothrombin fragment 1+2, VCAM-1 and ICAM-1 and change in<br /><br>15(S)-8-iso-prostaglandin levels in 24 hours urine samples.</p><br>