Sublingual Microcirculation in Children with Compensated T1D Using the SDF Method

NCT05958264 | Completed

• 1 other identifier: 310/1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type1diabetes

Keywords

Microcirculation; Children; Type1diabetes

Outcome Measures

Primary Outcomes (8)

• Determination of Total Vascular Density of sublingual microcirculation of children with T1D

  Total length of vessels divided by total surface of area

  baseline

• Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of children with T1D

  The image is divided into four quadrants and the predominant type of flow (absent = 0, intermittent = 1, sluggish = 2, normal = 3, and hyperdynamic = 4) is assessed in each quadrant. The MFI score represents the averaged values of the four. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).

  baseline

• Determination of Small Vessel Density of sublingual microcirculation of children with T1D

  Total length of small vessels divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).

  baseline

• Determination of Proportion of Perfused Vessels (all) of sublingual microcirculation of children with T1D

  The proportion of perfused vessels (PPV \[%\]) can be calculated as follows: 100 × (total number of vessels - \[no flow + intermittent flow\])/total number of vessels.

  baselina

• Determination of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation of children with T1D

  The proportion of perfused small vessels (PPSV \[%\]) can be calculated as follows: 100 × (total number of small vessels - \[no flow + intermittent flow\])/total number of small vessels. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).

  baseline

• Determination of Perfused Vessel Density (PVD) of sublingual microcirculation of children with T1D

  Total length of vessels - (no flow + intermittent flow) divided by total surface of area

  baseline

• Determination of Perfused Small Vessel Density (PSVD) of sublingual microcirculation of children with T1D

  Total length of small vessels - (small vessels with no flow + intermittent flow) divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).

  baseline

• Determination of DeBacker Score of sublingual microcirculation of children

  In this score, three equidistant horizontal and three equidistant vertical lines are drawn on the screen. Vessel density can be calculated as the number of vessels crossing the lines divided by the total length of the lines. Higher number means better microcirculation.

  baseline

Secondary Outcomes (24)

• Differences in Total Vascular Density of sublingual microcirculation in different age and gender categories in children with T1D

  baseline

• Differences in Microvascular Flow Index (MFI) of sublingual microcirculation in different age and gender categories in children with T1D

  baseline

• Differences in Small Vessel Density of sublingual microcirculation in different age and gender categories in children with T1D

  baseline

• Differences Proportion of Perfused Vessels (all) of sublingual microcirculation in different age and gender categories in children with T1D

  baseline

• Differences in Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation in different age and gender categories in children with T1D

  baseline

Study Arms (3)

Children of younger school age

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

Children in puberty

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

Postpubertal adolescents

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

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include 40 children with T1D. Of these, 10 pre-school children (3-5.9 years), 10 younger school children (6-10.9 years), 10 children in puberty(11-14.9 years) and 10 post-puberty adolescents will be included (15-18.9 years).

You may qualify if:

• type 1 diabetes mellitus
• informed consent of parents

You may not qualify if:

• acute infection
• period of metabolic decompensation and 14 days after it

Sponsors & Collaborators

• Vlasta Krausová: lead

Study Sites (1)

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

Ústí nad Labem, Czechia

Location

Related Publications (1)

• 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.

  PMID: 41064468 DERIVED

Study Officials

• David Neumann, MD, Ph.D.

  Hospital in Trutnov

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 24, 2023
• Study Start: February 1, 2023
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CZ (1)