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Cardiometabolic Risk in Children With Type 1 Diabetes.

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ClinicalTrials.gov Identifier: NCT03544541
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Ljubljana, Faculty of Medicine

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
Type1 Diabetes Mellitus Metabolic Complication

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Association Between Metabolic Control and Cardiometabolic Risk in Children With Type 1 Diabetes.
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. Carotid Intima-Media Thickness [ Time Frame: 24 months ]
    Non-invasive (Doppler Ultrasound) measurement of Carotid Intima-Media Thickness



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Nationwide cohort of children and adolescents with type 1 diabetes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544541


Contacts
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Contact: Brigita Mali +386-1-522-9235 brigita.mali@kclj.si

Locations
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Slovenia
UMC-University Children's Hospital Recruiting
Ljubljana, Slovenia
Contact: Brigita Mali    +386 1 522 92 35    brigita.mali@kclj.si   
Sponsors and Collaborators
University of Ljubljana, Faculty of Medicine

Additional Information:

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Responsible Party: University of Ljubljana, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT03544541     History of Changes
Other Study ID Numbers: Cardio-Risk-T1D-SI
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases