Cardiometabolic Risk in Children With Type 1 Diabetes.

Type1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544541
• Other study ID #: Cardio-Risk-T1D-SI
• Status: Completed
• Start date: January 5, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: November 2019
• Source: University of Ljubljana, Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Metabolic Complication
• Type1 Diabetes Mellitus

Locations

Country	Name	City	State
Slovenia	UMC-University Children's Hospital	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid Intima-Media Thickness	Non-invasive (Doppler Ultrasound) measurement of Carotid Intima-Media Thickness	24 months