Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorSteno Diabetes Center Copenhagen

About this trial

Aims: To investigate early markers of long-term diabetic complications and the association to an extended glucose metabolic profile comprising glucose control (current and past), glucose variability and insulin sensitivity in children and adolescents with type 1 diabetes (T1D).

Background: Most Danish children and adolescents with T1D do not achieve their metabolic target and are at increased risk of developing long-term diabetic complications, reducing their life expectancy and increase their morbidity rate. Hence, improved metabolic control, a better understanding of what optimal metabolic control means, combined with detailed monitoring of the first markers of long-term complications and their reversibility or lack thereof are needed.

Methods: A prospectivel study of 400 children, aged 6-18 years old, with T1D\>12 months. Early markers of long-term diabetic complications will be investigated as arterial stiffness, nerve dysfunction and nephropathy. Data on T1D onset, duration, treatment modality, self-monitoring-blood-glucose profiles, growth, weight, and pubertal status will be collected.

Blood sampling will include routine tests and markers of glucose, lipid, bone, and gastrointestinal metabolism. DXA-scan, Fibroscan, bone-age, eye-examination and physical activity will be measured. Data on retrospective glucose- and lipid-profiles will be collected. The children will be offered a followup every 5 years for the next two decades.

Perspectives: This study provides novel insight into the frequency of early markers of long-term diabetic complications and its association to the interplay of the pancreas, adipose, gastrointestinal and bone metabolic axis. Which can assist in identifying subgroups of children and adolescents requiring earlier in-depth screening for early markers of long-term diabetic complications, for putative interventions for prevention, hence reducing morbidity and mortality in T1D.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

T1D>12 months

6-18 years old prior to inclusion

Followed at the Pediatric Diabetes outpatient clinic at Steno Diabetes Center Copenhagen

Speaks and reads Danish well enough to understanding the given oral and written information.

Disqualifiers

T1D < 12 months

Known cardiovascular disease

Antihypertensive treatment

Trial population

400 children or adolescents with type 1 diabetes for more than 12 months. Age between 6-18 years old.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 1 trial group
Group A: Prospective cohort study (observational)

Trial outcomes

Primary outcomes

1

Arterial stiffness in children and adolescent with type 1 diabetes (T1D) > 12 months and its association to glycemic control (current and past).

PWV is a measure of arterial stiffness (m/s) which can be done non invasively at bedside using a device called SphygmoCor CVMS machine (Atcor Medical, Sydney, Australia).

Time frame
15.01.2022-15.02.2024
2

Peripheral neuropathy assed by DPN-check in children and adolescent with type 1 diabetes (T1D) > 12 months

Neuropathy assesed by DPN-check: Sural Nerve conduction velocity(m/s) of the Sural nerves by DPN-check.

Time frame
15.01.2022-15.02.2024
3

Autonom neuropathy assed by Sudoscan in children and adolescent with type 1 diabetes (T1D) > 12 months

Neuropathy assesed by Sudoscan: Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance (µS) in feet

Time frame
15.01.2022-15.02.2024
4

Prevalence of cardivascular autonomic neuropathy assed by VagusDevice in children and adolescent with type 1 diabetes (T1D) > 12 months

The examination consists of 4 measures, all aimed at measuring heart rate. Measurements are taken for 5 minutes rest, change of position from lying to standing position, during deep breathing and by Valsalva (by breathing in a mouthpiece with a 40 mmHg resistance).

Time frame
15.01.2022-15.02.2024

Secondary outcomes

1

The association between early markers of diabetic complications and glycemic control

Hba1c (mmol/mol)

Time frame
15.01.2022-15.02.2024
2

The association between early markers of diabetic complications and glycemic control

Continous glucose monitoring (time in range (70-180mg/dL))

Time frame
15.01.2022-15.02.2024

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Steno Diabetes Center Copenhagen

Lead sponsor

Steno Diabetes Center Sjaelland

Collaborator