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Completed

NCT Number: NCT05958264

Sublingual Microcirculation in Children with Compensated T1D Using the SDF Method

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.

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Key information

Conditions

Type1diabetes

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Ústí nad Labem, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 1 diabetes mellitus
  • informed consent of parents

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Determination of Total Vascular Density of sublingual microcirculation of children with T1D

    Time frame: baseline

    Total length of vessels divided by total surface of area

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

    Time frame: baseline

    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).

  3. Determination of Small Vessel Density of sublingual microcirculation of children with T1D

    Time frame: baseline

    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).

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

    Time frame: baselina

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

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

    Time frame: baseline

    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).

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

    Time frame: baseline

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

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

    Time frame: baseline

    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).

  8. Determination of DeBacker Score of sublingual microcirculation of children

    Time frame: baseline

    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.

Secondary outcomes

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

    Time frame: baseline

    Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.

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

    Time frame: baseline

    Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.

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

    Time frame: baseline

    Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.

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

    Time frame: baseline

    Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.

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

    Time frame: baseline

    Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.

  6. Differences in Perfused Vessel Density (PVD) of sublingual microcirculation in different age and gender categories in children with T1D

    Time frame: baseline

    Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.

  7. Differences in Perfused Small Vessel Density (PSVD) of sublingual microcirculation in different age and gender categories in children with T1D

    Time frame: baseline

    Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.

  8. Differences in DeBacker Score of sublingual microcirculation in different age and gender categories in children with T1D

    Time frame: baseline

    Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females. Higher number means better microcirculation.

  9. Correlation of Total Vascular Density of sublingual microcirculation with parameters of diabetic compenzation

    Time frame: baseline

    Comparison of parametes in children with good and bad compenzation of T1D

  10. Correlation of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of diabetic compenzation

    Time frame: baseline

    Comparison of parametes in children with good and bad compenzation of T1D

  11. Correlation of Small Vessel Density of sublingual microcirculation with parameters of diabetic compenzation

    Time frame: baseline

    Comparison of parametes in children with good and bad compenzation of T1D

  12. Correlation of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of diabetic compenzation

    Time frame: baseline

    Comparison of parametes in children with good and bad compenzation of T1D

  13. Correlation of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of diabetic compenzation

    Time frame: baseline

    Comparison of parametes in children with good and bad compenzation of T1D

  14. Correlation of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of diabetic compenzation

    Time frame: baseline

    Comparison of parametes in children with good and bad compenzation of T1D

  15. Correlation of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of diabetic compenzation

    Time frame: baseline

    Comparison of parametes in children with good and bad compenzation of T1D

  16. Correlation of DeBacker Score of sublingual microcirculation with parameters of diabetic compenzation

    Time frame: baseline

    Comparison of parametes in children with good and bad compenzation of T1D

  17. Differences of Total Vascular Density of sublingual microcirculation with parameters of healthy children in the same age categories

    Time frame: baseline

    Total Vascular Density of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228

  18. Differences of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of healthy children in the same age categories

    Time frame: baseline

    Microvascular Flow Index (MFI) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228

  19. Differences of Small Vessel Density of sublingual microcirculation with parameters of healthy children in the same age categories

    Time frame: baseline

    Small Vessel Density of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228

  20. Differences of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of healthy children in the same age categories

    Time frame: baseline

    Proportion of Perfused Vessels (all) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228

  21. Differences of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of healthy children in the same age categories

    Time frame: baseline

    Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228

  22. Differences of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of healthy children in the same age categories

    Time frame: baseline

    Perfused Vessel Density (PVD) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228

  23. Differences of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of healthy children in the same age categories

    Time frame: baseline

    Perfused Small Vessel Density (PSVD) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228

  24. Differences of DeBacker Score of sublingual microcirculation with parameters of healthy children in the same age categories

    Time frame: baseline

    DeBacker Score of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228

Sponsors and collaborators

Lead sponsor

Vlasta Krausová

Other

Registry information

Official study title

Evaluation of Sublingual Microcirculation Using Sidestream Dark-Field Imaging in Children with Type 1 Diabetes Mellitus with Favorable Treatment Outcomes.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2023
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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