NCT02687152

CompletedPhase 1/2

Arginase Inhibition and Microvascular Endothelial Function i...

Karolinska Institutet Source

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Other study identifiers

Sponsor study identifier

Micro Arginase

Study Type

interventional

Actual enrollment (reported)

24

Locations

1 country

Sites

1

Timeline

Study Start

March 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2015

Actual (reported)

Study Completion

January 2016

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 24 participants
Study completion date: January 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2014
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)
Study Completion
January 2016
Actual (reported)
First Submitted
February 9, 2016
Actual (reported)
First Posted
February 22, 2016
Actual (reported)

Last Updated: February 22, 2016
Status Verified: February 2016
Last Update Submitted: February 16, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

Change in cutaneous microvascular endothelial function
Laser Doppler flow rate
2 hours

Study Arms (1)

Arginase inhibition

EXPERIMENTAL

N-hydroxyl-nor-L-arginine, i.a. 0.1 mg/min for 120 min

Other: N-hydroxy-nor-L-arginine

Interventions

N-hydroxy-nor-L-arginineOther

Arginase inhibition

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Karolinska Institutet
Otherlead

Study Sites (1)

Karolinska Institutet

Stockholm, 17176, Sweden

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

N(omega)-hydroxynorarginine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

John Pernow, MD, PhD
Karolinska Institutet
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD, PhD

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 22, 2016

Study Start

March 2014

Date type not reported

This date has not been verified as actual or estimated.

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Phase 1/2Terminated

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

Contact the study team to confirm eligibility.

Primary Completion

November 2015

Actual (reported)

Study Completion

January 2016

Actual (reported)

Last Updated

February 22, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02687152
Data provider: ClinicalTrials.gov
Source updated: 2016-02-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:59 UTC

Locations

SE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Arginase inhibition

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations