Sublingual Microcirculation in Children with Compensated T1D Using the SDF Method

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05958264

Enrollment

Registered

2023-07-24

Start date

2023-02-01

Completion date

2024-09-15

Last updated

2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1diabetes

Keywords

Microcirculation, Children, Type1diabetes

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

Inclusion criteria

* type 1 diabetes mellitus * informed consent of parents

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Determination of Total Vascular Density of sublingual microcirculation of children with T1D	baseline	Total length of vessels divided by total surface of area
Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of children with T1D	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).
Determination of Small Vessel Density of sublingual microcirculation of children with T1D	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).
Determination of Proportion of Perfused Vessels (all) of sublingual microcirculation of children with T1D	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.
Determination of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation of children with T1D	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).
Determination of Perfused Vessel Density (PVD) of sublingual microcirculation of children with T1D	baseline	Total length of vessels - (no flow + intermittent flow) divided by total surface of area
Determination of Perfused Small Vessel Density (PSVD) of sublingual microcirculation of children with T1D	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).
Determination of DeBacker Score of sublingual microcirculation of children	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

Measure	Time frame	Description
Correlation of Total Vascular Density of sublingual microcirculation with parameters of diabetic compenzation	baseline	Comparison of parametes in children with good and bad compenzation of T1D
Correlation of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of diabetic compenzation	baseline	Comparison of parametes in children with good and bad compenzation of T1D
Correlation of Small Vessel Density of sublingual microcirculation with parameters of diabetic compenzation	baseline	Comparison of parametes in children with good and bad compenzation of T1D
Correlation of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of diabetic compenzation	baseline	Comparison of parametes in children with good and bad compenzation of T1D
Correlation of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of diabetic compenzation	baseline	Comparison of parametes in children with good and bad compenzation of T1D
Correlation of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of diabetic compenzation	baseline	Comparison of parametes in children with good and bad compenzation of T1D
Correlation of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of diabetic compenzation	baseline	Comparison of parametes in children with good and bad compenzation of T1D
Correlation of DeBacker Score of sublingual microcirculation with parameters of diabetic compenzation	baseline	Comparison of parametes in children with good and bad compenzation of T1D
Differences in Total Vascular Density of sublingual microcirculation in different age and gender categories in children with T1D	baseline	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.
Differences of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of healthy children in the same age categories	baseline	Microvascular Flow Index (MFI) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228
Differences of Small Vessel Density of sublingual microcirculation with parameters of healthy children in the same age categories	baseline	Small Vessel Density of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228
Differences of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of healthy children in the same age categories	baseline	Proportion of Perfused Vessels (all) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228
Differences of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of healthy children in the same age categories	baseline	Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228
Differences of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of healthy children in the same age categories	baseline	Perfused Vessel Density (PVD) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228
Differences of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of healthy children in the same age categories	baseline	Perfused Small Vessel Density (PSVD) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228
Differences of DeBacker Score of sublingual microcirculation with parameters of healthy children in the same age categories	baseline	DeBacker Score of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228
Differences of Total Vascular Density of sublingual microcirculation with parameters of healthy children in the same age categories	baseline	Total Vascular Density of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228
Differences in Microvascular Flow Index (MFI) of sublingual microcirculation in different age and gender categories in children with T1D	baseline	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.
Differences in Small Vessel Density of sublingual microcirculation in different age and gender categories in children with T1D	baseline	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.
Differences Proportion of Perfused Vessels (all) of sublingual microcirculation in different age and gender categories in children with T1D	baseline	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.
Differences in Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation in different age and gender categories in children with T1D	baseline	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.
Differences in Perfused Vessel Density (PVD) of sublingual microcirculation in different age and gender categories in children with T1D	baseline	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.
Differences in Perfused Small Vessel Density (PSVD) of sublingual microcirculation in different age and gender categories in children with T1D	baseline	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.
Differences in DeBacker Score of sublingual microcirculation in different age and gender categories in children with T1D	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.

Countries

Czechia

Outcome results