Sublingual Microcirculation in Children with Compensated T1D Using the SDF Method

October 16, 2024 updated by: Vlasta Krausová

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Czechia
      • Ústí Nad Labem, Czechia
        • Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria:

  • type 1 diabetes mellitus
  • informed consent of parents

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline
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).
baseline
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).
baseline
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.
baselina
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).
baseline
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
baseline
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).
baseline
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.
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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.
baseline
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.
baseline
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.
baseline
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.
baseline
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.
baseline
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.
baseline
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.
baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vlasta Krausová

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: David Neumann, MD, Ph.D., Hospital in Trutnov

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 310/1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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