NCT05806502

Brief Summary

To evaluate the efficacy of arginase inhibition on endothelial function in patients with type 1 diabetes and type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

4.5 years

First QC Date

March 28, 2023

Last Update Submit

June 19, 2024

Conditions

Type 1 DiabetesType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Endothelium-dependant increase in forearm blood flow

    Change in forearm blood flow

    120 minutes

Study Arms (2)

Type 1 diabetes

EXPERIMENTAL

Endothelium-dependent and -independent vasodilatation before and after 120 min intra-arterial administration of arginase the inhibitor N-omega-hydroxy-nor-l-arginine (nor-NOHA).

Diagnostic Test: Nω-hydroxy-nor-arginine

Type 2 diabetes

EXPERIMENTAL

Endothelium-dependent and -independent vasodilatation before and after 120 min intra-arterial administration of arginase the inhibitor N-omega-hydroxy-nor-l-arginine (nor-NOHA).

Diagnostic Test: Nω-hydroxy-nor-arginine

Interventions

Nω-hydroxy-nor-arginineDIAGNOSTIC_TEST

Arginase inhibitor

Type 1 diabetesType 2 diabetes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes
  • Type 2 diabetes

You may not qualify if:

  • Age \>80 years
  • Acute coronary or ischemic event during the last three months
  • Vascular surgery of the arm
  • Peripheral vascular disease affecting the arm
  • Ongoing anticoagulant medication
  • Any concomitant disease or condition that may interfere with the possibility for the patient 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 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • John Pernow, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

November 1, 2018

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations

SE(1)