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.
Investigators
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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