type1diabetes Clinical Trial
Official title:
Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes
NCT number | NCT05159856 |
Other study ID # | H-20038547 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 3, 2022 |
Est. completion date | December 2025 |
Aims: To investigate early markers of arterial stiffness and nerve dysfunction 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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | Inclusion Criteria: - 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. - There is a written consent from the guardianship holder/holders for the child. Exclusion Criteria: - T1D < 12 months - Known cardiovascular disease - Antihypertensive treatment |
Country | Name | City | State |
---|---|---|---|
Denmark | Steno Diabetes Center Copenhagen | Herlev |
Lead Sponsor | Collaborator |
---|---|
Steno Diabetes Center Copenhagen | Steno Diabetes Center Sjaelland |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 15.01.2022-15.02.2024 | |
Primary | 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. | 15.01.2022-15.02.2024 | |
Primary | 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 |
15.01.2022-15.02.2024 | |
Primary | 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). | 15.01.2022-15.02.2024 | |
Secondary | The association between early markers of diabetic complications and glycemic control | Hba1c (mmol/mol) | 15.01.2022-15.02.2024 | |
Secondary | The association between early markers of diabetic complications and glycemic control | Continous glucose monitoring (time in range (70-180mg/dL)) | 15.01.2022-15.02.2024 |
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