NCT03480945

Brief Summary

Study objective To evaluate the mechanism behind endothelial dysfunction in patients with type 2 diabetes in relation to the level of glycaemic control. Primary endpoint: Change in endothelium dependent vasodilatation (EDV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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

January 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

March 20, 2018

Last Update Submit

February 19, 2020

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    Change in endothelium-dependent dilatation

    8 weeks

Interventions

serotoninDIAGNOSTIC_TEST

Endothelium-dependent dilatation

Also known as: nitroprusside

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Study Population

Type 2 diabetes Healthy controls

You may qualify if:

  • Type 2 diabetes
  • Poor glycaemic control defined as a mean day blood glucose \>12 mmol/L.

You may not qualify if:

  • Age \>80 years.
  • HbA1c \<70 mmol/mol
  • Myocardial infarction/unstable angina within 6 weeks prior to the study.
  • Treatment with oral anticoagulants (Warfarin or New oral anticoagulants)
  • Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm.
  • Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
  • Participant in an ongoing study.
  • Unwillingness to participate following oral and written information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 29, 2018

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

July 31, 2019

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations

SE(1)