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OpenTrials
Completed

NCT Number: NCT03544541

Cardiometabolic Risk in Children With Type 1 Diabetes.

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.

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Key information

Conditions

Type1 Diabetes Mellitus Metabolic Complication

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC-University Children's Hospital

Ljubljana, Slovenia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Carotid Intima-Media Thickness

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

University of Ljubljana, Faculty of Medicine

Other

Registry information

Official study title

Association Between Metabolic Control and Cardiometabolic Risk in Children With Type 1 Diabetes.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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