Clinical trial NCT05958264: Sublingual Microcirculation in Children with Compensated T1D Using the SDF Method
Official title: Evaluation of Sublingual Microcirculation Using Sidestream Dark-Field Imaging in Children with Type 1 Diabetes Mellitus with Favorable Treatment Outcomes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1diabetes
Keywords: Microcirculation
Children
Type1diabetes
Lead sponsor: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes mellitus
* informed consent of parents

Exclusion Criteria:

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

Primary outcomes:
measure: Determination of Total Vascular Density of sublingual microcirculation of children with T1D
timeFrame: baseline
measure: Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of children with T1D
timeFrame: baseline
measure: Determination of Small Vessel Density of sublingual microcirculation of children with T1D
timeFrame: baseline
measure: Determination of Proportion of Perfused Vessels (all) of sublingual microcirculation of children with T1D
timeFrame: baselina
measure: Determination of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation of children with T1D
timeFrame: baseline
measure: Determination of Perfused Vessel Density (PVD) of sublingual microcirculation of children with T1D
timeFrame: baseline
measure: Determination of Perfused Small Vessel Density (PSVD) of sublingual microcirculation of children with T1D
timeFrame: baseline
measure: Determination of DeBacker Score of sublingual microcirculation of children
timeFrame: baseline
Secondary outcomes:
measure: Differences in Total Vascular Density of sublingual microcirculation in different age and gender categories in children with T1D
timeFrame: baseline
measure: Differences in Microvascular Flow Index (MFI) of sublingual microcirculation in different age and gender categories in children with T1D
timeFrame: baseline
measure: Differences in Small Vessel Density of sublingual microcirculation in different age and gender categories in children with T1D
timeFrame: baseline
measure: Differences Proportion of Perfused Vessels (all) of sublingual microcirculation in different age and gender categories in children with T1D
timeFrame: baseline
measure: Differences in Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation in different age and gender categories in children with T1D
timeFrame: baseline
measure: Differences in Perfused Vessel Density (PVD) of sublingual microcirculation in different age and gender categories in children with T1D
timeFrame: baseline
measure: Differences in Perfused Small Vessel Density (PSVD) of sublingual microcirculation in different age and gender categories in children with T1D
timeFrame: baseline
measure: Differences in DeBacker Score of sublingual microcirculation in different age and gender categories in children with T1D
timeFrame: baseline
measure: Correlation of Total Vascular Density of sublingual microcirculation with parameters of diabetic compenzation
timeFrame: baseline
measure: Correlation of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of diabetic compenzation
timeFrame: baseline
measure: Correlation of Small Vessel Density of sublingual microcirculation with parameters of diabetic compenzation
timeFrame: baseline
measure: Correlation of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of diabetic compenzation
timeFrame: baseline
measure: Correlation of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of diabetic compenzation
timeFrame: baseline
measure: Correlation of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of diabetic compenzation
timeFrame: baseline
measure: Correlation of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of diabetic compenzation
timeFrame: baseline
measure: Correlation of DeBacker Score of sublingual microcirculation with parameters of diabetic compenzation
timeFrame: baseline
measure: Differences of Total Vascular Density of sublingual microcirculation with parameters of healthy children in the same age categories
timeFrame: baseline
measure: Differences of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of healthy children in the same age categories
timeFrame: baseline
measure: Differences of Small Vessel Density of sublingual microcirculation with parameters of healthy children in the same age categories
timeFrame: baseline
measure: Differences of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of healthy children in the same age categories
timeFrame: baseline
measure: Differences of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of healthy children in the same age categories
timeFrame: baseline
measure: Differences of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of healthy children in the same age categories
timeFrame: baseline
measure: Differences of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of healthy children in the same age categories
timeFrame: baseline
measure: Differences of DeBacker Score of sublingual microcirculation with parameters of healthy children in the same age categories
timeFrame: baseline
Other outcomes:
Locations:
city: Ústí Nad Labem
country: Czechia
facility: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Study officials:
affiliation: Hospital in Trutnov
name: David Neumann, MD, Ph.D.
role: STUDY_CHAIR
References: