NCT03544541

Brief Summary

To access the relationship between metabolic control of children and adolescents with type 1 diabetes and cardiometabolic risk through noninvasive imaging modalities to assess the early vasculature changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

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 5, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

February 5, 2020

Status Verified

November 1, 2019

Enrollment Period

1.9 years

First QC Date

February 27, 2018

Last Update Submit

January 31, 2020

Conditions

Type1 Diabetes MellitusMetabolic Complication

Outcome Measures

Primary Outcomes (1)

  • Carotid Intima-Media Thickness

    Non-invasive (Doppler Ultrasound) measurement of Carotid Intima-Media Thickness

    24 months

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Nationwide cohort of children and adolescents with type 1 diabetes

You may qualify if:

  • Type 1 diabetes for more than 0.5 year
  • Age ≥ 10 years up to 25 years (inclusive)
  • The subject/carer is willing to follow study specific instructions

You may not qualify if:

  • Youth with maturity-onset diabetes of the young, hybrid, other, or missing type
  • Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study
  • Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC-University Children's Hospital

Ljubljana, Slovenia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

June 1, 2018

Study Start

January 5, 2018

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

February 5, 2020

Record last verified: 2019-11

Locations

SL(1)