Sublingual Microcirculation in Children With Compensated T1D Using the SDF Method

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958264
• Other study ID #: 310/1
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
• Contact: Vlasta Krausova, MD
• Phone: +420777883572
• Email: vlahado[@]seznam.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• type 1 diabetes mellitus
• informed consent of parents

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1diabetes

Locations

Country	Name	City	State
Czechia	Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.	Ústí Nad Labem

Sponsors (1)

Lead Sponsor	Collaborator
Vlasta Krausová

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of Total Vascular Density of sublingual microcirculation of children with T1D	Total length of vessels divided by total surface of area	baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Differences in Total Vascular Density of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Secondary	Differences in Microvascular Flow Index (MFI) of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Secondary	Differences in Small Vessel Density of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Secondary	Differences Proportion of Perfused Vessels (all) of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Secondary	Differences in Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Secondary	Differences in Perfused Vessel Density (PVD) of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Secondary	Differences in Perfused Small Vessel Density (PSVD) of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Secondary	Differences in DeBacker Score of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years and males vs. females. Higher number means better microcirculation.	baseline
Secondary	Correlation of Total Vascular Density of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Secondary	Correlation of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Secondary	Correlation of Small Vessel Density of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Secondary	Correlation of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Secondary	Correlation of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Secondary	Correlation of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Secondary	Correlation of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Secondary	Correlation of DeBacker Score of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Secondary	Differences of Total Vascular Density of sublingual microcirculation with parameters of healthy children in the same age categories	Total Vascular Density of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Secondary	Differences of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of healthy children in the same age categories	Microvascular Flow Index (MFI) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Secondary	Differences of Small Vessel Density of sublingual microcirculation with parameters of healthy children in the same age categories	Small Vessel Density of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Secondary	Differences of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of healthy children in the same age categories	Proportion of Perfused Vessels (all) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Secondary	Differences of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of healthy children in the same age categories	Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Secondary	Differences of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of healthy children in the same age categories	Perfused Vessel Density (PVD) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Secondary	Differences of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of healthy children in the same age categories	Perfused Small Vessel Density (PSVD) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Secondary	Differences of DeBacker Score of sublingual microcirculation with parameters of healthy children in the same age categories	DeBacker Score of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline