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Clinical Trials/NCT03544541
NCT03544541
Completed
Not Applicable

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

University of Ljubljana, Faculty of Medicine1 site in 1 country150 target enrollmentJanuary 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type1 Diabetes Mellitus
Sponsor
University of Ljubljana, Faculty of Medicine
Enrollment
150
Locations
1
Primary Endpoint
Carotid Intima-Media Thickness
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2018
End Date
November 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Ljubljana, Faculty of Medicine
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Carotid Intima-Media Thickness

Time Frame: 24 months

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

Study Sites (1)

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