Clincosm LogoSign in Get a demo

Cardiometabolic Risk in Children With Type 1 Diabetes.

Sponsor
University of Ljubljana, Faculty of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03544541
Collaborator
(none)
150
Enrollment
1
Location
22.8
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Association Between Metabolic Control and Cardiometabolic Risk in Children With Type 1 Diabetes.
    Actual Study Start Date :
    Jan 5, 2018
    Actual Primary Completion Date :
    Nov 30, 2019
    Actual Study Completion Date :
    Nov 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Carotid Intima-Media Thickness [24 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 25 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UMC-University Children's Hospital Ljubljana Slovenia

    Sponsors and Collaborators

    • University of Ljubljana, Faculty of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Ljubljana, Faculty of Medicine
    ClinicalTrials.gov Identifier:
    NCT03544541
    Other Study ID Numbers:
    • Cardio-Risk-T1D-SI
    First Posted:
    Jun 1, 2018
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Feb 5, 2020