Sublingual Microcirculation in Children with Compensated T1D Using the SDF Method

NCT ID: NCT05958264

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-09-15

Brief Summary

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The main goal of the study is to describe the sublingual microcirculation of children with type 1 diabetes mellitus (T1D) with stable and satisfactory treatment of the disease and to compare it with previously measured parameters of healthy children, NCT05324228.

Detailed Description

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After recording the basic anthropometric parameters, pressure and pulse, each child who meets the inclusion criteria will have their microcirculation measured using a Sidestream Dark-Field (SDF) probe placed sublingually by one examiner using the SDF method. The measurement will be performed in supine position in a disease-free period, with normal diets, at least 2 hours after the last meal, for girls outside the menses period. Premedication or analgesia will not be used. A total of 3 video clips will be recorded from different parts of the sublingual area with a minimum length of 20 seconds in a row, unless the child needs a short break between measurements. The recorded videos will then be processed offline by one evaluator who is trained and experienced in microcirculation evaluation, three best and most stable parts of each video clip will be analysed.

Conditions

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Type1diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Children of younger school age

10 children of younger school age aged 6-10,9 years with T1D.

No interventions assigned to this group

Children in puberty

10 children in puberty aged 11-14,9 years with T1D

No interventions assigned to this group

Postpubertal adolescents

10 postpubertal adolescents aged 15-18,9 years with T1D

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* type 1 diabetes mellitus
* informed consent of parents

Exclusion Criteria

* acute infection
* period of metabolic decompensation and 14 days after it
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vlasta Krausová

OTHER

Sponsor Role lead

Responsible Party

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Vlasta Krausová

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Neumann, MD, Ph.D.

Role: STUDY_CHAIR

Hospital in Trutnov

Locations

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Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Ústí nad Labem, , Czechia

Site Status

Countries

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Czechia

References

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Krausova V, Neumann D, Stichova L, Skvor J, Dostalova V, Dostal P. Alterations of Sublingual Microcirculation in Children With Compensated Type 1 Diabetes Mellitus-An Observational Study. Pediatr Diabetes. 2025 Sep 30;2025:8811411. doi: 10.1155/pedi/8811411. eCollection 2025.

Reference Type DERIVED
PMID: 41064468 (View on PubMed)

Other Identifiers

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310/1

Identifier Type: -

Identifier Source: org_study_id

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