Arginase Inhibition and Microvascular Endothelial Function in Type 2 Diabetes

Effect of Arginase Inhibition on Microvascular Endothelial Function in Patients With Type 2 Diabetes and Microvascular Dysfunction.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02687152

Enrollment

Registered

2016-02-22

Start date

2014-03-31

Completion date

2016-01-31

Last updated

2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

The present project is designed to test the hypothesis that arginase contributes to microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular complications.

Detailed description

Background The development of microvascular complications in diabetes is a complex process, in which endothelial dysfunction is of importance. Emerging evidence suggests that arginase is a key mediator of endothelial dysfunction in type 2 diabetes mellitus (T2DM) by reciprocally regulating nitric oxide bioavailability. The aim of this study was to test the hypothesis that arginase activity is increased and that arginase contributes to microvascular endothelial function in patients with T2DM and microvascular dysfunction. Method Microvascular endothelium-dependent and -independent vasodilatation are investigated in patients with T2DM (n =12) and healthy age-matched control subjects (n =12) with laser-Doppler flowmetry during iontophoretic application of acetylcholine and sodium nitroprusside, respectively, before and after intra-arterial administration of the arginase inhibitor N-hydroxy-nor-L-arginine (0.1 mg/min) for 120 min.

Interventions

OTHERN-hydroxy-nor-L-arginine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of type 2 diabetes mellitus and microvascular dysfunction defined as microalbuminuria \> 3.0 mg/mmol or presence of retinopathy.

Exclusion criteria

* Myocardial infarction or unstable angina within the last three months, * Changed dose of any vasodilator drug during the preceding six weeks, * Ongoing treatment with warfarin * Concomitant disease that may have interfered with the possibility for the patients to comply with or complete the study protocol

Design outcomes

Primary

Measure	Time frame	Description
Change in cutaneous microvascular endothelial function	2 hours	Laser Doppler flow rate

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026