NCT02687152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

February 9, 2016

Last Update Submit

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

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:

  • 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.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17176, Sweden

Location

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

Study Design

Study Type
interventional
Phase
phase 1
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 1, 2014

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

February 22, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)